Boston Scientific recalls IceRod i-Thaw Prostate Cryoablation Kits with needle shaft gas leaks. Affected units have specific UDI and batch numbers. Stop using immediately if you own one.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IceRod i-Thaw Prostate Cryoablation Kits due to reported needle shaft gas leaks. This could potentially cause issues during medical procedures, so affected users should stop using the device immediately.
The needle shaft in the kit can leak gas, which may cause unintended cooling or other complications during the procedure. This could lead to tissue damage or other medical issues if the leak occurs during treatment.
Patients undergoing prostate cryoablation procedures who own the recalled IceRod i-Thaw kits are most at risk. Healthcare providers using the device may also be affected.
Check for the unique device identifier (UDI) numbers listed: 7290104830105 and 7290104830075. Also look for batch numbers like U1363, U0865, or U0555 on the packaging or label.
If you have the recalled IceRod i-Thaw Prostate Cryoablation Kit, stop using it right away to prevent potential complications.
The recalled device is the IceRod i-Thaw Prostate Cryoablation Kit with specific UDI numbers and batch numbers listed in the recall notice.
Check the unique device identifier (UDI) numbers on your kit: 7290104830105 or 7290104830075. Also look for batch numbers like U1363, U0865, or U0555 on the packaging or label.
Stop using the kit immediately and contact Boston Scientific for further instructions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0691-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0691-2021 from Boston Scientific. 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.
