Boston Scientific recalls specific cryoablation needles due to unexpected surface deterioration during procedures. Affected units include certain batch numbers and model types sold for surgical use.
The needle surface deteriorated due to unexpected electrolysis during procedure.
Boston Scientific is recalling certain cryoablation needles that may have deteriorated surfaces during use. This could potentially cause complications during surgical procedures if the needles are used without proper condition.
The needles' surfaces deteriorate unexpectedly during surgical procedures due to electrolysis. This deterioration could lead to improper tissue destruction or other complications if the needles are used without being properly checked.
Surgical professionals using the recalled needles for cryoablation procedures are most at risk. Patients undergoing these procedures with the affected needles could experience complications.
Check for the model name 'Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles' or 'Galil Medicals 2.1 CX Cryoablation Needles'. Affected units have batch numbers including A0904, A1085, A1177, A1178, A6681, A6682, A6962, A6963, A6977, A7113, U0084.
Look for batch numbers on the needle packaging: A0904, A1085, A1177, A1178, A6681, A6682, A6962, A6963, A6977, A7113, or U0084.
Reach out to Boston Scientific directly for further guidance on handling affected needles.
The recall indicates a potential risk of surface deterioration during procedures, so they should not be used without checking the batch number and contacting Boston Scientific first.
Check the batch number on the packaging. If it matches the listed batches, contact Boston Scientific for instructions on safe handling or disposal.
The needles are labeled as 'Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles' or 'Galil Medicals 2.1 CX Cryoablation Needles' with specific batch numbers listed in the recall.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2682-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2682-2020 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.
