Boston Scientific recalls IceRod Prostate Cryoablation Kits with needle shaft gas leaks. Affected units have specific batch numbers and UDIs. Stop using immediately to prevent potential injury.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IceRod Prostate Cryoablation Kits due to reported needle shaft gas leaks. This could lead to unintended medical complications during procedures. Affected units have specific batch numbers and unique device identifiers.
The needle shaft in the kit may leak gas, which could cause unintended tissue damage or complications during medical procedures. This hazard is reported through patient complaints but has not been confirmed to cause serious injury in normal use.
Patients undergoing prostate cryoablation procedures using the recalled kits are most at risk. Healthcare providers who have purchased or used these kits may also be affected.
Check the batch numbers on the kit: U0412, U0029, U0039, T0775, T0687, T0675, A1873, A1866, A1820, A1643, A1420, A1226. Also look for unique device identifiers (UDIs) starting with 7290104830082.
Discontinue use of the IceRod Prostate Cryoablation Kit if it has the listed batch numbers or UDIs.
The recall is for needle shaft gas leaks in the IceRod Prostate Cryoablation Kit, which could lead to unintended tissue damage during procedures.
Check the batch numbers on the kit: U0412, U0029, U0039, T0775, T0687, T0675, A1873, A1866, A1820, A1643, A1420, A1226. Also look for unique device identifiers (UDIs) starting with 7290104830082.
The recall record does not specify a return process or replacement options.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0688-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0688-2021 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.
