Boston Scientific recalls Five IceSphere Prostate Cryoablation Kits with needle shaft gas leaks. Affected units have specific batch numbers and UDIs. Consumers should check their kit's details to determine if it's recalled.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling Five IceSphere Prostate Cryoablation Kits due to reported needle shaft gas leaks. This could potentially cause issues during medical procedures, so affected users should verify their kit's details and contact the company for guidance.
The recall is based on complaints about needle shaft gas leaks in the kits. While the exact risk isn't specified, gas leaks could potentially cause complications during medical procedures if the kit is used improperly.
Patients undergoing prostate cryoablation procedures who own the recalled Five IceSphere kits are most at risk. The recall affects specific batch numbers and units sold with unique identifiers.
Check the kit's batch numbers listed in the recall (e.g., U1402, U1223) or unique identifiers (UDIs) such as 7290104830969. The recall includes multiple units with the same UDIs and batch numbers.
Review the batch numbers and unique identifiers (UDIs) on your Five IceSphere Prostate Cryoablation Kit to see if it matches the recalled units listed in the notice.
Boston Scientific is recalling the Five IceSphere Prostate Cryoablation Kits due to complaints about needle shaft gas leaks, which could potentially cause complications during medical procedures.
Check the batch numbers (e.g., U1402, U1223) and unique identifiers (UDIs) on your kit against the list provided in the recall notice.
Contact Boston Scientific directly to confirm if your kit is affected and follow their instructions for next steps.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0689-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0689-2021 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.
