Penumbra JET 7 Reperfusion Catheter Recalled for Potential Tip Damage
Penumbra Inc. is recalling JET 7 Reperfusion Catheters because distal tip damage could cause vessel injury or death during use.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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 the Penumbra JET 7 Reperfusion Catheter and Penumbra Hi-Flow Aspiration Tubing (Catalog Number 5MAXJET7L138KIT). The recall covers lot numbers F97123 through F98981. The source text notes that none of these specific units were distributed.
The recall is issued because the catheter may become susceptible to distal tip damage during use. If this damage occurs in conjunction with pressurization of contrast injection, it may result in potential vessel damage, leading to patient injury or death.
The product was distributed worldwide, including the United States and various international markets. Because the source states that no units were distributed, there are no specific consumers or patients currently affected by this recall.
The recalled product
- Product
- Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT 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…
- Manufacturer
- Penumbra Inc.
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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