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December 15, 2020: Penumbra Issues Urgent Recall of JET 7 Catheters with Xtra Flex Technology Due to Increased Risk of Serious Injury and Death

Penumbra’s JET 7 Xtra Flex Catheter Recall News – Penumbra issued a recall for all models of its JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) due to unexpected deaths and serious injuries while being used for removing clots in stroke patients.

Penumbra’s JET 7 Xtra Flex Catheter Recall Information

On December 15, 2020, Penumbra issued an urgent recall for consumers and providers for all configurations of the JET 7 Xtra Flex due to “unexpected death or serious injury” while the affected product was being used for removing clots in stroke patients. Use of the JET 7 Xtra Flex should cease immediately and facilities should take the affected devices out of their inventory.

The affected JET 7 Xtra Flex devices include:

  • All lots of Penumbra JET 7 Reperfusion Catheter and Penumbra Hi-Flow Aspiration Tubing with Catalog Number (REF): 5MAXJET7KIT and UDI: 00815948020962
  • All lots of Penumbra JET 7 Reperfusion Catheter and Penumbra Hi-Flow Aspiration Tubing with Catalog Number (REF): 5MAXJET7L138KIT and UDI: 00815948021594
  • All lots of Penumbra JET 7 Reperfusion Catheter with Catalog Number (REF): 5MAXJET7 and UDI: 00815948020955

The Standard Tip Penumbra JET 7 Reperfusion Catheter is not subject to this recall.

According to the U.S. Food and Drug Administration’s (FDA) Penumbra JET 7 Xtra Flex recall announcement,

“The FDA has received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including deaths, serious injuries, and malfunctions. Twenty of these MDRs describe 14 unique patient deaths, which include reports from different reporting sources for a single adverse event. Other MDRs describe serious patient injury such as vessel damage, hemorrhage, and cerebral infarction. Device failure modes reported in the MDRs include ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter.”

Penumbra performed bench testing, where the JET 7 Xtra Flex catheters’ distal tip is plugged and pressurized to failure, which demonstrated that it was not able to withstand the same burst pressures to failure as Penumbra’s other large bore aspiration catheters used to remove thrombus in acute ischemic stroke patients.

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