Boston Scientific recalls IcePearl 2.1 CX Prostate Cryoablation Kits 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 IcePearl 2.1 CX Prostate Cryoablation Kits due to complaints about needle shaft gas leaks. This could potentially cause issues during medical procedures if the leak occurs.
The needle shaft in the kit may leak gas, which could cause unintended cooling or other complications during medical procedures. This is a complaint trend, not a confirmed hazard in all cases.
Patients undergoing prostate cryoablation procedures who use the recalled kits. Medical professionals using the kits for treatment are most at risk.
Check for batch numbers U1308, U1304, U1066, U1034, U0859, U0860, U0661, U0660, U0609, U0588, T0815, T0816, T0270, T0238, T0212, T0211, T0181, T0144, T0055, A7122, A7027, A7014, A6926, A6913, A6900, A6857, A6744, A6710, A1937, A1583, A1461. The kit has a unique identifier (UDI) starting with 7290104831065.
Review the batch numbers and unique identifiers (UDIs) on the kit to confirm if it is affected.
The recall is based on complaints about needle shaft gas leaks, but no confirmed injuries have been reported. The risk is low.
Check the batch numbers listed: U1308, U1304, U1066, U1034, U0859, U0860, U0661, U0660, U0609, U0588, T0815, T0816, T0270, T0238, T0212, T0211, T0181, T0144, T0055, A7122, A7027, A7014, A6926, A6913, A6900, A6857, A6744, A6710, A1937, A1583, A1461. The kit has a unique identifier (UDI) starting with 7290104831065.
Contact Boston Scientific directly to confirm if your kit is affected and get 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-0685-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0685-2021 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.
