Penumbra JET 7MAX Kits Recalled for Potential Vessel Damage Risk
Penumbra Inc. is recalling JET 7MAX Kits because catheter tip damage during use could cause vessel damage, leading to patient injury or death.
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 due to the potential for fatalities.
Plain-English summary
Penumbra Inc. is recalling 15 units of the Penumbra JET 7MAX KIT (REF J7XKIT132). This medical device kit includes the JET 7 Reperfusion Catheter, MAX Delivery Device, and Hi-Flow Aspiration Tubing. The recall covers specific lot numbers ranging from C21487 to C21772 and F97946 to F98497.
The recall is issued because the catheter may become susceptible to distal tip damage during use. If this damage occurs in conjunction with pressurized contrast injection, it may result in potential vessel damage, which could lead to patient injury or death.
The affected products were distributed worldwide, including nationwide in the United States and in various countries such as Canada, Japan, and the United Arab Emirates. Healthcare facilities and users should stop using the affected lots and contact Penumbra Inc. for further instructions.
The recalled product
- Product
- Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132 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…
- Manufacturer
- Penumbra Inc.
- Affected units
- 15
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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