Boston Scientific recalls specific prostate cryoablation needles due to needle surface deterioration from unexpected electrolysis during procedures. Affected units include certain batch numbers and model types sold for prescription use.
The needle surface deteriorated due to unexpected electrolysis during procedure.
Boston Scientific is recalling prostate cryoablation needles that may deteriorate due to unexpected electrolysis during surgery. This could lead to needle failure during procedures, potentially causing injury to patients.
The needle surface deteriorates due to unexpected electrolysis during surgical procedures. This could cause the needle to fail during use, potentially leading to injury to the patient.
Prescription-only prostate cryoablation procedures using the specific needle models. Patients undergoing these procedures with the affected batch numbers are most at risk.
Check for the product name: Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System. Affected units have batch numbers A1105, A1193, A1291, A1435, A1550, A1565, A1776, A1781, A6758, A6930, A7062, or A7061, T0153.
Identify the batch number on the needle packaging to determine if it is affected.
The needle surface deteriorates due to unexpected electrolysis during surgical procedures, which could cause needle failure.
Check the batch number on the packaging; affected units include specific batch numbers listed in the recall notice.
The recall does not specify a remedy, so 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-2678-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2678-2020 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.
