Boston Scientific recalls specific prostate cryoablation kits due to needle surface deterioration from unexpected electrolysis during procedures. Affected units include certain batch numbers and model types. Consumers should contact the company for details.
The needle surface deteriorated due to unexpected electrolysis during procedure.
Boston Scientific is recalling prostate cryoablation kits that may have needle surfaces deteriorating during procedures due to unexpected electrolysis. This could lead to potential complications if the needles fail during surgery.
The needle surface deteriorates from unexpected electrolysis during surgery, which could cause the needle to become unsafe or malfunction. This might lead to complications during the cryoablation procedure if the needle fails.
Patients undergoing prostate cryoablation procedures who use the specific kit models and batch numbers listed. Medical professionals performing the procedure are most at risk.
Check for the model name 'Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE System' and batch numbers listed in the recall notice. The product is prescription-only and sold under the brand Galil Medicals.
Reach out to Boston Scientific directly for specific instructions on how to get the recalled kit replaced or repaired.
The recall is due to a risk of needle surface deterioration during procedures, which could lead to complications. However, the specific hazard is not described as causing serious injury in normal use.
Affected batch numbers include A1194, A1298, A1436, A1569, A1567, A1782, A6754, A6757, A6848, A6849, A6915, T0154, T0163, T0552, U0083.
Check the product label for the model name 'Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE System' and batch numbers 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-2680-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2680-2020 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.
