Boston Scientific recalls IceFORCE 2.1 CX Cryoablation Needles (Prescription Only) with specific batch numbers due to needle surface deterioration from unexpected electrolysis during procedures.
The needle surface deteriorated due to unexpected electrolysis during procedure.
Boston Scientific is recalling certain IceFORCE 2.1 CX Cryoablation Needles because the needle surface deteriorates during procedures due to unexpected electrolysis. This could lead to potential complications during surgical tissue destruction.
The needle surface deteriorates during procedures due to unexpected electrolysis, which could cause potential complications during surgical tissue destruction. This issue occurs when the needle is used in cryoablation procedures.
Medical professionals using these cryoablation needles for surgical procedures are affected. Patients undergoing the specific procedures with recalled needles are at risk.
Check the batch numbers listed in the recall: A0754 through A1999 and T0004 through T0099, U0022 through U0191. These needles are prescription-only and intended for surgical procedures.
Immediately stop using the recalled cryoablation needles if you have them.
The affected batch numbers are A0754 through A1999 and T0004 through T0099, U0022 through U0191.
No, the recalled needles have a risk of surface deterioration during procedures due to unexpected electrolysis, so they should not be used.
Check the batch numbers on the needle packaging; the affected batches are listed in the recall notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2675-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2675-2020 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.
