Boston Scientific recalls IceFORCE 2.1 CX Prostate Cryoablation Kits with needle shaft gas leaks. Affected units have specific batch numbers and UDIs. Stop using immediately to avoid potential risks.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IceFORCE 2.1 CX Prostate Cryoablation Kits due to reported needle shaft gas leaks. This could lead to unintended medical complications during procedures. Affected kits have specific batch numbers and unique device identifiers.
The recall addresses complaints about gas leaks in the needle shaft. If gas leaks occur during use, it could potentially cause unintended tissue damage or complications during the procedure. However, the exact risk level and how it impacts safety are not clearly specified in the recall notice.
Patients undergoing prostate cryoablation procedures who own the recalled kits are affected. Medical professionals using these kits for treatments are at risk if they have the affected units.
Check the batch numbers listed: U1302, U1303, U1301, U1032, U0616, U0590, U0589, U0583, U0540, U0363, U0318, U0083, T0552, T0163, T0154, A6915, A6849, A6848, A6757, A6754, A1782, A1569, A1567, A1436, A1298, A1194. Also, look for the unique device identifiers (UDIs) provided: 7290104831058 repeated multiple times.
Discontinue use of the recalled IceFORCE 2.1 CX Prostate Cryoablation Kit if you have it.
The recall addresses complaints about needle shaft gas leaks, which could potentially cause unintended tissue damage during procedures.
Check the batch numbers listed: U1302, U1303, U1301, U1032, U0616, U0590, U0589, U0583, U0540, U0363, U0318, U0083, T0552, T0163, T0154, A6915, A6849, A6848, A6757, A6754, A1782, A1569, A1567, A1436, A1298, A1194. Also, look for the unique device identifiers (UDIs) provided: 7290104831058 repeated multiple times.
Stop using the kit immediately and contact Boston Scientific for further instructions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0684-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0684-2021 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.
