Boston Scientific recalls IceFORCE 2.1 CX Cryoablation Needles with gas leaks. Affected units have specific batch numbers and UDIs. Stop using if you own one to prevent potential complications.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IceFORCE 2.1 CX Cryoablation Needles due to reported gas leaks in the needle shaft. This could lead to complications during medical procedures if the device is used without proper leak detection.
The needle shaft may leak gas, which could cause complications during medical procedures if the device is used without proper leak detection. This is a complaint trend, not a confirmed safety issue.
Medical professionals who use the IceFORCE 2.1 CX Cryoablation Needle for procedures. Those with the specific batch numbers or UDIs listed are most at risk.
Check the product's batch numbers (U0903, U0785, etc.) or Unique Device Identifiers (UDIs) listed in the recall notice. The affected needles have specific serial numbers and batch codes.
Identify your needle's batch numbers or Unique Device Identifiers (UDIs) to confirm if it's affected.
The recall is based on complaint trends of needle shaft gas leaks, but it has not been confirmed as a safety issue. Boston Scientific is taking action to address potential complications.
Check the batch numbers (U0903, U0785, etc.) or Unique Device Identifiers (UDIs) listed in the recall notice. Affected units have specific serial numbers.
The recall 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-0658-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0658-2021 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.
