Penumbra recalls JET 7MAX kits due to potential distal tip damage during use, which could cause vessel injury or death if contrast injection pressure is applied. Affected units have specific lot numbers.
The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.
Penumbra is recalling its JET 7MAX kit because the catheter's distal tip can get damaged during use. If this damage happens while pressurizing contrast injection, it might cause serious vessel injury or death. This recall affects specific production batches.
The catheter's distal tip can become damaged during use. If this damage occurs while pressurizing contrast injection, it may cause vessel injury or death due to the pressure being applied to the damaged area.
Healthcare professionals using the Penumbra JET 7MAX kit for neurointervention procedures are most at risk. Patients receiving treatment with this kit could be affected if the catheter malfunctions.
Check the lot number range on the packaging: C21487 through C21772 for the catheter component. The product has a specific catalog number J7XKIT132 and UDI code 00815948021273.
Look for the lot number range C21487 through C21772 on the catheter packaging.
The Penumbra JET 7MAX kit (J7XKIT132) with Xtra Flex technology is recalled.
Check the lot number range on the packaging: C21487 through C21772 for the catheter component.
The recall record does not specify a remedy, so contact Penumbra for guidance.
We’ve drafted a message you can send Penumbra to request your refund or repair — edit it as you like.
Subject: Recall Z-0851-2021 — Penumbra Penumbra Hello, I own a Penumbra that is covered by recall Z-0851-2021 from Penumbra. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
