Penumbra JET 7 Reperfusion Catheter Recalled for Potential Vessel Damage
Penumbra Inc. is recalling JET 7 Reperfusion Catheters because distal tip damage could cause vessel injury or death during use.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states that the defect may result in 'patient injury or death,' which meets the rubric criteria for a Critical severity score.
Plain-English summary
Penumbra Inc. is recalling 27,499 units of the Penumbra JET 7 KIT Reperfusion Catheter and Penumbra Hi-Flow Aspiration Tubing. The recall covers specific lot numbers ranging from C15441 to C19176 and F88882 to F100278. The product is distributed worldwide, including the United States and numerous international locations.
The recall is issued because the catheter may become susceptible to distal tip damage during use. If this damage occurs in conjunction with the pressurization of contrast injection, it may result in potential vessel damage, leading to patient injury or death.
Healthcare providers and facilities should stop using the affected devices immediately. Users should contact Penumbra Inc. for instructions on returning the product or obtaining a replacement.
The recalled product
- Product
- Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump t
- Manufacturer
- Penumbra Inc.
- Affected units
- 27,499
Distribution
Part of a larger recall action
This product is one of 4 recalled by Penumbra Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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