Boston Scientific recalls IceSeed Prostate Cryoablation Kit with reported needle shaft gas leaks. Affected units have specific batch numbers and UDIs. Consumers should contact for details.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling its IceSeed Prostate Cryoablation Kit due to complaints about needle shaft gas leaks. This could potentially cause issues during medical procedures, though the exact risk isn't specified in the recall notice.
The recall mentions complaints about needle shaft gas leaks. Gas leaks could potentially cause issues during medical procedures, but the exact mechanism and severity aren't clearly described in the notice.
Patients undergoing prostate cryoablation procedures using the recalled kit are most at risk. Healthcare providers who have purchased or used the kit may also be affected.
Check for batch numbers U1262, U1114, U1036, U0910, U0909, U0863, U0365, U0280, U0281, U0180, U0088, U0038, T0529, T0457, T0235, T0178, T0058, A6911, A6835, A6695, A6648, A2133, A2040, A2033, A1889, A1634, A1368, A1225 on the kit. Also look for unique device identifiers (UDIs) 7290104830075.
Identify the batch numbers and unique device identifiers (UDIs) on the IceSeed Prostate Cryoablation Kit to determine if it's affected.
The recall mentions complaints about needle shaft gas leaks, but the exact risk isn't specified in the notice.
Check for batch numbers U1262, U1114, U1036, U0910, U0909, U0863, U0365, U0280, U0281, U0180, U0088, U0038, T0529, T0457, T0235, T0178, T0058, A6911, A6835, A6695, A6648, A2133, A2040, A2033, A1889, A1634, A1368, A1225 on the kit. Also look for unique device identifiers (UDIs) 7290104830075.
The recall does not specify a remedy, so contact Boston Scientific directly 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-0692-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0692-2021 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.
