Penumbra recalls JET 7 Reperfusion Catheter kits due to potential distal tip damage during use, which 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 can become damaged during use. This damage, combined with contrast injection pressure, might cause vessel injury or death in patients. The recall affects specific kit models sold in the U.S. with certain lot numbers.
The catheter tip can become damaged during use, and if contrast injection pressure is applied, this damage might cause vessel injury or death. This risk occurs when the catheter is used in neurovascular procedures to remove blood clots.
Healthcare professionals using the Penumbra JET 7 Reperfusion Catheter kits for neurovascular procedures are most at risk. Patients receiving treatment with these kits could be affected if the catheter tip becomes damaged.
Check for the kit model 'Penumbra JET 7 Reperfusion Catheter with Penumbra Hi-Flow Aspiration Tubing' and lot numbers F97123 through F98981. The recall applies to kits sold in the U.S. with these specific lot numbers.
Look for the lot number on the kit packaging, which should be between F97123 and F98981.
If you have the kit, contact Penumbra Inc. for further instructions on how to handle the product.
The recall affects the medical devices used in procedures, so patients receiving treatment with these kits could be at risk if the catheter tip becomes damaged.
Check the kit packaging for the lot number range F97123 through F98981. The recall applies to kits sold in the U.S. with these specific lot numbers.
Contact Penumbra Inc. for instructions on how to handle the product. The recall note states that none of these kits were distributed, so you may not have this product.
We’ve drafted a message you can send Penumbra to request your refund or repair — edit it as you like.
Subject: Recall Z-0850-2021 — Penumbra Penumbra Hello, I own a Penumbra that is covered by recall Z-0850-2021 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.
