Boston Scientific recalls IcePearl 2.1 CX Prostate Cryoablation Kit due to reported needle shaft gas leaks. Affected units have specific batch numbers and UDIs. Consumers should check their kit for these identifiers.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IcePearl 2.1 CX Prostate Cryoablation Kits after complaints about needle shaft gas leaks. This could potentially cause issues during medical procedures if the kit is used improperly.
The needle shaft in some units may leak gas, which could lead to unintended cooling or other complications during prostate cryoablation procedures. This risk is based on patient complaints but not confirmed to cause injury in normal use.
Patients undergoing prostate cryoablation procedures who own the recalled IcePearl 2.1 CX kits are most at risk. Healthcare providers using the kit for medical treatments may also be affected.
Check the kit's batch numbers listed in the recall: U1473, U1299, U1300, U1261, U1213, U1109, U1039, U1031, U0925, U0924, U0858, U0784, U0614, U0613, U0582, U0554, U0226, U0227, U0093, U0027, U0082, T0592, T0437, T0268, T0237, T0236, T0224, T0141, T0136, T0054, A7148, A7088, A7026, A7013, A6925, A6856, A6743, A6702, A2121, A2118, A1936, A1582, A1561, A1460, A1248, A1171. Also check the unique device identifiers (UDIs) listed: 7290104831041.
Look for batch numbers on the kit: U1473, U1299, U1300, U1261, U1213, U1109, U1039, U1031, U0925, U0924, U0858, U0784, U0614, U0613, U0582, U0554, U0226, U0227, U0093, U0027, U0082, T0592, T0437, T0268, T0237, T0236, T0224, T0141, T0136, T0054, A7148, A7088, A7026, A7013, A6925, A6856, A6743, A6702, A2121, A2118, A1936, A1582, A1561, A1460, A1248, A1171.
Check the unique device identifiers (UDIs) on the kit: 7290104831041.
The recall is based on complaints about needle shaft gas leaks, which could lead to unintended cooling during procedures. However, the hazard has not been confirmed to cause injury in normal use.
Check your kit's batch numbers against the list: U1473, U1299, U1300, U1261, U1213, U1109, U1039, U1031, U0925, U0924, U0858, U0784, U0614, U0613, U0582, U0554, U0226, U0227, U0093, U0027, U0082, T0592, T0437, T0268, T0237, T0236, T0224, T0141, T0136, T0054, A7148, A7088, A7026, A7013, A6925, A6856, A6743, A6702, A2121, A2118, A1936, A1582, A1561, A1460, A1248, A1171. Also check the UDIs: 7290104831041.
The recall does not include a specific remedy, so affected users should contact Boston Scientific directly for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0683-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0683-2021 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.
