Penumbra JET 7 Reperfusion Catheter Recalled for Potential Tip Damage
Penumbra Inc. is recalling 3,368 JET 7 Reperfusion Catheters because the distal tip may become damaged during use, posing a risk of vessel damage and 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 'subsequent 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 3,368 units of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (Catalog Number 5MAXJET7). The device is a component of the Penumbra system used to deliver aspiration to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature.
The recall was initiated because the catheter may become susceptible to distal tip damage during use. According to the source text, distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.
The affected units were distributed worldwide, including nationwide in the United States and in various countries outside the U.S. such as Canada, Japan, and the United Arab Emirates. Specific lot numbers affected include C15558 thru C17703, F87621 thru F101011, and H10851. Healthcare facilities and users should stop using the affected devices and contact Penumbra Inc. for further instructions.
The recalled product
- Product
- Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 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 to the site of occlusion to assist in the…
- Manufacturer
- Penumbra Inc.
- Affected units
- 3,368
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.
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