There are no reviews yet, would you like to submit yours? From the start of aspiration to complete resolution of thrombus, the total device time with Lightning 12 was about 15 minutes, with a total procedure time of only 47 minutes ( Figure 3 and . $100.00) Model #: PNSF130SIM OEM: Penumbra System Expiration Date: 2019 Size: 5Fr x 130cm x .040" UPC: Current Stock: This item is out of stock. 6F Select Catheter. Physician was using penumbra neuron select 6f catheter in a routine procedure. In Stock! I have worked with the penumbra catheter, it's an aspiration catheter . I have found these catheter require more distal intracranial position for stability and are best positioned in conjunction with a Penumbra Select diagnostic catheter and 035 in Glidewire. Secondarily, we investigated treatment-dependent and treatment-independent . From the start of aspiration to complete resolution of thrombus, the total device time with Lightning 12 was about 15 minutes, with a total procedure time of only 47 minutes (Figures 3 and 4). Individual Coils; Delivery Microcatheter; Detachment Handle . $649.00 box of 1 - Penumbra # BMK6F95BER120 - Penumbra Benchmark 071 Intracranial Access Catheter Kit The Glidesheath Slender sheath is exchanged out, and the BGC is advanced over a 6F Sim Select intermediate catheter (Penumbra, Alameda, California, USA). Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization laboratories with use in select cases. If a distal position is not initially established, this . The leaders of Penumbra, an extraordinarily successful Alameda, California - based manufacturer of neurovascular devices, have recently found themselves on the horns of this very dilemma. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. Neuron Select Catheter-SIM-5Fr x 120cm x .040" Penumbra System. 2022 Penumbra, Inc. www.penumbrainc . Subsequently, the microcatheter and micro-guidewire were removed and a 20 ml syringe was connected to the proximal hub of the Penumbra catheter. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. Full radiopaque distal shaft. 2022 Penumbra, Inc. www.penumbrainc . Penumbra Select catheters do not have hydrophilic coating Neuron 5 F Select | 120/130 cm.040" I 5F Support Zone Max Zone 5.5 F (.070") OD Distal Flexible Zone 25 cm 9 cm 5.5F 5 F Select | 120/130 cm Designed to deliver soft-tipped BENCHMARK 071 and Neuron 070 Intracranial Access Catheters Not designed to deliver 6 F Long Sheath To start viewing messages, select the forum that you want to visit from the selection below.. Forums. Once that was cleared, a Neuron Select catheter (Penumbra, Inc.) was used to obtain access to the distal branches, where thrombus was still present. Overview. Description Additional Information Reviews (0) Reviews. Neuron 6Fr Select Catheter - Sim-V - 6Fr x 125cm x 8cm x .040" Penumbra System. Select catheter (Penumbra, Inc.) was used to obtain access to the distal branches, where thrombus was still present. With one pass, . Continuous manual aspiration was performed with maintaining the vacuum state between the tip of Penumbra . Select TM Catheter Construction All Penumbra Select Catheters Stainless braided shaft with radiopaque polymer steam-shaped tip Tapered profile of each Select catheter optimized for seamless transition and torque response Penumbra Select catheters do not have hydrophilic coating Neuron 5F Select | 120/130 cm.040" I.D. DISCUSSION Neuron 6Fr Select Catheter - Simmons - 6Fr x 125cm x 8cm x .040" Penumbra System. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our . Offered pre-packaged with Penumbra 5 F Select Catheter for rapid delivery to final position, eliminating an over-the-wire exchange. . Penumbra sells its products to hospitals primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select . Penumbra Reperfusion Catheter, 6 Fr Size, 139 cm Length /Each. 6F Select Catheter. 1 -3 Manual aspiration thrombectomy (MAT) using a flexible aspiration catheter is an alternative technique for treating acute ischemic stroke, particularly cases refractory to stent-based thrombectomy (SBT). Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA. The Penumbra CAT RX catheter was used in a total of 34 patients, with 71% STEMI, 23% NSTEMI, 3% UA, and 3% new onset heart failure. UPC: Current Stock: This item is out of stock. (mm) PNS6F105H1 6 F Select Catheter, 105 H1 105 9 .040 (1.02) PNS6F105BER 6 F Select Catheter, 105 BER 105 9 .040 (1.02) PNS6F125H1 6 F Select Catheter, 125 H1 125 9 .040 (1.02) Penumbra, Inc. (NYSE: PEN) today announced that it is voluntarily recalling all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex). Ships Today! Neuron 5Fr Select Catheter - SIM - 5Fr x 130cm x .040" Penumbra System. This report is associated with mfr report number: 3005168196-2020-00849. Manufacturer Narrative Conclusion: this device is available for return. Code Information: Catalog Number: PNS5f130H1; Lot Number: F15174. Optimized shaft for support throughout aortic arch. . 3MAX Reperfusion Catheter. 6 F (2.03 mm) long sheath.088 (2.24 mm) lumen allows for a wide range of device compatibility. Penumbra is recalling JET 7 Xtra Flex because the catheter may become susceptible to distal tip damage during use. bioburden. Neuron 6F Select; Neuron 5F Select; DDC; Ruby Coil. PNS5F130SIM: Penumbra Neuron 5F 040 Select Catheter 130/9cm SIM. enable primary delivery of our access devices for rapid, atraumatic placement into final position, eliminating the need for an . The recall follows a July warning letter from the company to healthcare providers. BMK6F95MBER120. Recalling Firm/ Manufacturer: Penumbra Inc. Photos are for illustration purposes only and may not depict the exact item. Dive Brief: Penumbra recalled its Jet 7 Xtra Flex catheter device due to the risk of injuries and even death while removing clots in stroke patients, following advice from FDA. ALAMEDA, Calif., Dec. 15, 2020 /PRNewswire/ -- Penumbra, Inc. (NYSE: PEN) today announced that it is voluntarily recalling all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex). Penumbra and FDA notified healthcare professionals of the Class 1 recall of the Neuron 5F Select Catheter, used to remove blood clots or foreign objects from blood vessels. . PNS5F130SIM: Penumbra Neuron 5F 040 Select Catheter 130/9cm SIMIn-Date & Expired Penumbra Guiding Catheters. The Penumbra Select Catheter is designed to assist in the navigation into the neurovasculature. (mm) PNS6F105H1 6 F Select Catheter, 105 H1 105 9 .040 (1.02) PNS6F105BER 6 F Select Catheter, 105 BER 105 9 .040 (1.02) PNS6F125H1 6 F Select Catheter, 125 H1 125 9 .040 (1.02) If you or somebody you know was injured by a defective Penumbra Jet 7 catheter, you should contact our lawyers immediately for a free case consultation. Login. 5MAXJET7KIT Penumbra JET 7 Reperfusion Catheter + Penumbra Hi-Flow Tubing 6.0 F (.085") 2.16 F .072" .072" 132 cm 5MAXJETDKIT Penumbra JET D Reperfusion Catheter + Penumbra Hi-Flow Tubing 6.0 F (.080") 1.65 F .064" .054" 138 cm . pica catheter: PENUMBRA, INC. . $100.00) Model #: PNS6F125BER OEM: Penumbra System Expiration Date: 2021 Size: 6Fr x 125cm x .040" UPC: Current Stock: This item is out of stock. Class I Recall for Select Catheters Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.. Neuron 6F Select; Neuron 5F Select; DDC; Ruby Coil. $89.00 /Each. $100.00) Model #: PNS6F125SIMV OEM: Penumbra System Expiration Date: 2021 Size: 6Fr x 125cm x 8cm x .040" UPC: Current Stock: This item is out of stock. Penumbra, Inc. (Neuro) Penumbra System Reperfusion Catheter JET 7, JET D, ACE, 5MAX, 4MAX, 3MAX, 026 6 (Penumbra JET 7, Penumbra JET D, ACE and 5MAX require 8-F short sheath or 6-F long sheath) 0.014-0.016: 132-160: Direct aspiration and separator-assisted clot debulking if needed Offered pre-packaged with Penumbra 5F Select Catheter for rapid delivery to final position, eliminating an over-the-wire exchange. Individual Coils; Delivery Microcatheter; Detachment Handle . 2022 Penumbra, Inc. www.penumbrainc . Introduction. and through distributors in select . Penumbra is recalling JET 7 Xtra Flex because the catheter may become susceptible to distal tip damage during use. A 3MAX catheter (Penumbra, Inc.) was used to provide support to navigate ACE64 to the thrombus. Penumbra, Inc . The device was manufactured on or about May 26, 2009 and distributed from May 5 . Intended for the introduction of interventional devices into the peripheral, coronary and neuro vasculature. Free! . Messages 8 Location Creswell, OR Best answers 0. 4 -7 Recent studies have suggested that MAT . Qty Avail: 0. 5 6 7 Using a digital roadmap or overlay reference angiogram, a steerable hydrophilic wire and angled catheter can be used to select the thrombosed branches and a DSA hand injection (2-3 mL contrast) can be performed to confirm appropriate catheter position prior to . . BMK6F95MBER120. $100.00) Model #: PNS5F120SIM OEM: Penumbra System Expiration Date: 2019 Size: 5Fr x 120cm x .040" UPC: Current Stock: This item is out of stock. Write a review. You must be . Penumbra Select Catheters enable Rapid Primary Access into final position, eliminating the need for an over-the-wire exchange. Optimized shaft for support throughout aortic arch. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our . 1 2 3 5 6 As part of the Indigo Aspiration System, the Indigo Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the . select catheter. Some surgeons have alleged that while they attempted to remove blood clots from patients' brains, Penumbra's newest catheter would occasionally break or . ALAMEDA, Calif.--(BUSINESS WIRE)-- Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, announced that the CHEETAH clinical study of its Indigo System CAT RX Catheter successfully met the primary endpoint and demonstrated high rates of blood clot removal, blood flow restoration and myocardial perfusion . $100.00) Model #: PNS6F125SIM OEM: Penumbra System Expiration Date: 2019 Size: 6Fr x 125cm x 8cm x .040" UPC: Current Stock: This item is out of stock. This combination of intelligent aspiration and large-lumen catheter engineering makes Lightning 12 Penumbra's most advanced clot removal technology for the treatment of pulmonary embolism. Description Additional Information Reviews (0) Reviews. Neuron 6F Select; Neuron 5F Select; DDC; Ruby Coil. PNS6F105BER 6 F Select Catheter, 105 BER 105 cm PNS6F125SIM 6 F Select Catheter, 125 SIM 125 cm The primary aim of our study was to compare the procedural efficacy of the direct aspiration technique, using Penumbra ACE TM aspiration catheter, and the stent retriever technique, with a Solitaire TM FR stent. Benchmark 071 Catheter: 105cm, MP. The company announced the recall after the market closed Tuesday. Offered pre-packaged with Penumbra 5F Select Catheter for rapid delivery to final position, eliminating an over-the-wire exchange. Neuron SIM-V 6F Select Catheter, 125 cm Working Length . Penumbra Indigo System. On (b) (6) 2020, the patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max), a neuron select catheter 6f, a penumbra system jetd reperfusion catheter (jetd) and a velocity . Indications, Safety, and Warnings. Penumbra and FDA notified healthcare professionals of the Class 1 recall of the Neuron 5F Select Catheter, used to remove blood clots or foreign objects from blood vessels. Medical Coding. As of Dec. 15, 2020, Penumbra has . Penumbra System Coil 400 COMPLEX STANDARD - 24mm x 57cm - Non-Expired: 24mm x 57cm $750.00. Thereafter, we gently advanced the Penumbra catheter into the thrombus until wedged tightly. Penumbra Select Catheters enable Rapid Primary Access into final position, eliminating the need for an over-the-wire exchange. Neuron Select Catheter - Berenstein - 6Fr x 125cm x .040" Penumbra System. Add to cart. Reperfusion Catheter 026. 071 lumen, enabling dual device delivery. Write a review. PNS5F130H1: Penumbra Neuron 5F 040 Select Catheter 130/9cm H1 (No Box) In-Date Penumbra Guiding Catheters Photos are for illustration purposes only and may not depict the exact item. Register to see more details. Due to a manufacturing error, the catheters may contain pin holes and exposed wire braids which may result in a brain clot or a blood vessel puncture, and this may lead to . 5F Select Catheter: 120cm, BER. Out of stock. Indigo System CAT7 Aspiration Catheter with Lightning Intelligent Aspiration powered by Penumbra ENGINE is now commercially available in the U.S. . 6 F Select Catheters Tip Shape Working Length Distal Flexible Zone Inner Diameter Catalog Number Description (cm) (cm) (in.) Neuron Select Catheter - BER - 5Fr x .040" x 130cm Penumbra System. Price: $43.00 EACH. Neuron MAX 088 is designed for neurovascular use delivering MAX support for today's most advanced treatment options. Benchmark 071 Catheter: 95cm, Straight. The recall follows a July warning letter from the company to healthcare providers. PENUMBRA, INC. NEURON SELECT CATHETER 6F DQY: Back to Search Results: Model Number PNS6F125BER: Device Problem Break (1069) Patient Problem No Clinical Signs, Symptoms or Conditions (4582) Event Date 01/05/2022: Event Type malfunction Event Description The patient was undergoing a medical procedure in the pulmonary artery using a neuron select . Add to cart. There was no negative influence on the procedure or the patient's well-being. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. Designed to deliver 3D Revascularization Device; Compatible with Penumbra System : . Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA. We attempted to deliver the Neuron MAX 088 guide sheath over a 125-cm Simmons Select catheter into the left ICA. Full radiopaque distal shaft. All Electrophysiology (EP) Catheters Ablation - Irrigated Ablation - Non-Irrigated Steerable Irrigation . Register. The company announced the recall after the market closed Tuesday. J. julrey New. neurovascular access catheter, used to track the penumbra select catheter and keep it stable while ascending into aortas. The Neuron 5F Select Catheter is used to remove blood clots or foreign objects from blood vessels. 3MAX Reperfusion Catheter. Individual Coils; Delivery Microcatheter; Detachment Handle . . Qty Avail: 2-+ PENUMBRA: 5MAXACE068KIT . Now available in the U.S., RED 62 is engineered with optimized trackability to help navigate the complex distal vessel anatomy in the brain and deliver powerful aspiration for the removal of blood clots First catheter of new RED series expands the company's extensive portfolio of innovative stroke products Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative . Introduce the preloaded system over a guidewire and advance to a straight section of the abdominal aorta. You must be . Compatible with Penumbra 5 F (1.65 mm) Select Catheters for Rapid Primary Access delivery to final position, eliminating an over-the-wire exchange; Neuron 053.053 (1.35 mm) lumen for primary device delivery; 6 F (2.03 mm) proximal to 5 F (1.65 mm) distal tapered OD; 5 F Select Catheter Allows for easy selection off of arch into desired vessel Neuron Select Catheter - Simmons - 6Fr x .040" x 125cm - Non-Expired Penumbra System . PNS6F125H1 6 F Select Catheter, 125 H1 125 5.6 / 6.5 / 5 .040 .035 / .038 PNS6F125SIMV 6 F Select Catheter, 125 SIM-V 125 5.6 / 6.5 / 5 .040 .035 / .038 Ordering Information . clot capture capability through four intraluminal chambers and is optimized for use with aspiration delivered by ACE catheters or the Penumbra JET 7 Reperfusion catheter: $100.00) Model #: PNS5F130BER OEM: Penumbra System Expiration Date: 2021 Size: 5Fr x .040" x 130cm . Risk Information Caution: Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential . BMK6F95BER120. Distal tip damage in conjunction with . Add to cart. DESCRIPTION SIZE INFO SPECIFICATIONS X-RAY MARKER COMPATIBILITY CORNER VIDEOS DOWNLOADS. Unique Device Identifier (UDI) numbers provided by Penumbra are: 00815948020962, 00815948021594 and 00815948020955. There are no reviews yet, would you like to submit yours . Background: Mechanical thrombectomy is the standard therapy in patients with acute ischemic stroke (AIS). Sign in to add this product to your favorites! Only a few steps and you are ready! When inserting a syringe to inject contrast medium the luer hub at the proximal end broke. Enables primary access and atraumatic placement into desired vessel without an over-the-wire exchange; Useful for diagnostic angiogram - .040" lumen; Stainless steel braided proximal shaft for support and torque response with a soft polymer distal shaft to enable atraumatic vessel selection The Penumbra Indigo (Penumbra, Alameda, CA) . 6 F Select Catheters Tip Shape Working Length Distal Flexible Zone Inner Diameter Catalog Number Description (cm) (cm) (in.) On December 15, 2020, Penumbra, Inc. issued an "urgent recall" of its JET 7 Xtra Flex catheter, and JET 7MAX configuration (JET 7 Xtra Flex catheter attached to the MAX Delivery Device). Results of EXTRACT-PE Trial presented at Vascular InterVentional Advances (VIVA) Annual Meeting Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced that the EXTRACT-PE trial successfully met the primary endpoints, demonstrating the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with . Register for free to access our full content, including detailed information for each device. 071 lumen, enabling dual device delivery. Attention Lawyers: We consider a referral from another law . PENUMBRA: SEP3 . Penumbra Reperfusion Catheters and Separators and could result in damage to the JET 7 Reperfusion As part of the PENUMBRA SYSTEM, the Reperfusion . Penumbra and FDA notified healthcare professionals of the Class 1 recall of the Neuron 5F Select Catheter, used to remove blood clots or foreign objects from blood vessels. Description Additional Information Reviews (0) Reviews. ACE Reperfusion Catheter with Hi-Flow Aspiration Tubing, 6 Fr Size . The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy. BENCHMARK 071 5F Penumbra Select Catheter BENCHMARK 071 + 5F Penumbra Select Catheter Seamless transition zone with no shelf for atraumatic advancement. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. 5F Optimized proximal shaft for support throughout aortic arch. There are no reviews yet, would you like to submit yours? This catheter is used to remove foreign objects or blood clots from blood vessels. The Penumbra CAT RX appears to be safe and highly effective at thrombus removal .