Boston Scientific recalls IceRod He-Thaw Prostate Cryoablation Kits with needle shaft gas leaks. Affected units have specific batch numbers and UDIs. Stop using if you own the recalled model.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IceRod He-Thaw Prostate Cryoablation Kits due to reported needle shaft gas leaks. This could cause unintended gas release during medical procedures, potentially leading to complications for patients.
The needle shaft in the kit may leak gas during medical procedures. This could cause unintended gas release, potentially leading to complications such as tissue damage or procedural delays.
Patients undergoing prostate cryoablation procedures using the recalled kits are most at risk. Healthcare providers who have purchased or use these kits should check if their units are affected.
Check the batch numbers: G5063, G5871, G5900, G5902, G5975, P1901, P2150, P2204, P2206, P2207, P2240, P2241, P2242, P2243, P2245, P2247, P2249, P2251, P2253, P2254, P2256, P2258, P2259, P2261, P2262, P2263, P2268, P2272, P2274, P2404, P2405, P2406, P2411. Also check the Unique Device Identifiers (UDIs): 7290104830099 and 72901048300105.
Look for the batch numbers listed above or the Unique Device Identifiers (UDIs) provided in the recall notice.
Boston Scientific is recalling the IceRod He-Thaw Prostate Cryoablation Kit due to complaints about needle shaft gas leaks, which could cause unintended gas release during medical procedures.
Check the batch numbers: G5063, G5871, G5900, G5902, G5975, P1901, P2150, P2204, P2206, P2207, P2240, P2241, P2242, P2243, P2245, P2247, P2249, P2251, P2253, P2254, P2256, P2258, P2259, P2261, P2262, P2263, P2268, P2272, P2274, P2404, P2405, P2406, P2411. Also check the UDIs: 7290104830099 and 72901048300105.
The recall record does not specify a remedy, so contact Boston Scientific directly for guidance on 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-0693-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0693-2021 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.
