Penumbra recalls JET 7 Reperfusion Catheter REF 5MAXJET7 due to potential distal tip damage causing vessel injury or death during use. Affected units sold between 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 7 Reperfusion Catheter with Xtra Flex technology because it can become damaged at the tip during use. This damage, combined with contrast injection pressure, might cause vessel injury or death in patients. Patients using this device should stop using it immediately.
The catheter's distal tip can become damaged during use. When contrast injection pressure is applied, this damage may cause vessel injury or death in patients.
Healthcare professionals using the Penumbra JET 7 Reperfusion Catheter for neurovascular procedures are most at risk. Patients receiving treatment with this device could face serious injury or death.
Check for the catalog number 5MAXJET7 on the catheter. Affected units were sold with lot numbers C15558 through C17703 and F87621 through F101011.
Immediately stop using the Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 if it is in your possession.
The catalog number is 5MAXJET7.
Lot numbers C15558 through C17703 and F87621 through F101011.
The recall record does not mention any remedy or fix.
We’ve drafted a message you can send Penumbra to request your refund or repair — edit it as you like.
Subject: Recall Z-0848-2021 — Penumbra Penumbra Hello, I own a Penumbra that is covered by recall Z-0848-2021 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.
