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Penumbra's Recall of the JET 7 Reperfusion Catheter Due to ... | 合法醫療器材資訊網

Penumbra's Recall of the JET 7 Reperfusion Catheter Due to ...

2021年1月29日—OnDecember17,2020,PenumbrarecalledthePenumbraJET7XtraFlexbecausethecathetermaybecomesusceptibletodistaltipdamage ...

 Penumbra's Recall of the JET 7 Reperfusion Catheter Due to ...

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology, also known as JET 7 Xtra Flex All Lots Model or Catalog Numbers: The FDA’s Recall Classification Database[1] Manufacturing Dates:  May 10, 2019 – December 11, 2020 Distribution Dates: June 17, 2019 - December 14, 2020; 30,882 devices distributed Devices Recalled in the U.S.:  22,656 devices. Date Initiated by Firm: December 15, 2020 Device Use

As a component of the Penumbra System with the Penumbra Aspiration Pump and Penumbra Aspiration Tubing, the JET 7 Xtra Flex catheter and JET 7MAX configuration (JET 7 Xtra Flex catheter and MAX ...

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Penumbra JET ® Family | 合法醫療器材資訊網
The Penumbra JET® 7 Reperfusion Catheter is intended for use in the revascularization of patients with acute ischemic stroke secondary to large vessel occlusion. Read More
Penumbra JET™ 7 Reperfusion Catheter | 合法醫療器材資訊網
The Penumbra JET™ 7 Reperfusion Catheter is intended for use in the revascularization of patients with acute ischemic stroke secondary to large vessel occlusion ... Read More
Innovation | 合法醫療器材資訊網
The Penumbra JET 7 is the Penumbra System's seventh generation Reperfusion Catheter for proximal large vessel occlusions, and Penumbra JET D Reperfusion​ ... Read More
Penumbra Jet 7 Xtra Flex Catheter | 合法醫療器材資訊網
2021年2月3日 — How Does the Jet 7 Catheter Work? ... The Penumbra Jet 7 Xtra Flex Catheter enters the blood vessel and vacuums out the blood clot. The Jet 7 ... Read More
JET 7 Xtra Flex Catheters Recalled After Injuries and Deaths | 合法醫療器材資訊網
2020年12月21日 — JET 7 Xtra Flex catheters are a part of the Penumbra System with the Penumbra Aspiration Pump and Penumbra Aspiration Tubing. Medical ... Read More
Penumbra's Urgent Voluntary Recall of JET 7 Catheters with ... | 合法醫療器材資訊網
2021年1月29日 — The FDA has received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including deaths, serious injuries, ... Read More
Penumbra's Recall of the JET 7 Reperfusion Catheter Due to ... | 合法醫療器材資訊網
2021年1月29日 — On December 17, 2020, Penumbra recalled the Penumbra JET 7 Xtra Flex because the catheter may become susceptible to distal tip damage ... Read More
Penumbra Launches Jet 7 Reperfusion Catheter With Xtra ... | 合法醫療器材資訊網
2019年7月25日 — Penumbra Jet 7 with Xtra Flex technology is used with the Penumbra Engine in the fully integrated Penumbra System – an aspiration-based ... Read More
Utilization of the large | 合法醫療器材資訊網
由 AO Amireh 著作 · 被引用 1 次 — Background and purpose: The Penumbra JET 7 reperfusion catheter is used in the revascularization of large vessel occlusions in acute ischemic stroke. Read More
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