Penumbra recalls JET 7 Reperfusion Catheter kits due to potential distal tip damage during use that could cause vessel injury or death if contrast injection pressure is applied.
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 7 Reperfusion Catheter kits because the catheter tip may get damaged during use. This damage could cause vessel injury or death if contrast injection pressure is applied. Affected units were sold between specific lot numbers and dates.
The catheter tip can become damaged during use. If this damage occurs while pressurizing contrast injection, it could cause vessel injury or death.
Healthcare professionals using the Penumbra JET 7 Reperfusion Catheter kits for neurointervention procedures are most at risk. Patients receiving these procedures may be affected if the catheter is damaged.
Check for the lot number range C15441 to C19176 and the F88882 to F100278 on the packaging. The product is sold under the catalog number 5MAXJET7KIT.
Inspect the catheter tip for signs of damage before use.
Reach out to Penumbra Inc. for specific guidance on safe use or replacement options.
The catheter tip may become damaged during use, which could cause vessel injury or death if contrast injection pressure is applied.
Check for lot numbers C15441 to C19176 and F88882 to F100278 on the packaging, or catalog number 5MAXJET7KIT.
The recall record does not specify a remedy, so contact Penumbra Inc. 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-0849-2021 — Penumbra Penumbra Hello, I own a Penumbra that is covered by recall Z-0849-2021 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.
