Boston Scientific recalls specific IcePearl 2.1 CX Cryoablation Needles due to needle surface deterioration from unexpected electrolysis during procedures. Affected units include certain batch numbers and model codes.
The needle surface deteriorated due to unexpected electrolysis during procedure.
Boston Scientific is recalling IcePearl 2.1 CX Cryoablation Needles because the needle surface can deteriorate during procedures due to unexpected electrolysis. This could lead to potential complications during surgical use.
The needle surface deteriorates due to unexpected electrolysis during surgical procedures. This could potentially cause complications such as tissue damage or procedural failure if the needle becomes unstable or breaks during use.
Medical professionals using the recalled needles for cryoablation procedures are affected. Patients undergoing surgery with these needles may be at risk if the needle deteriorates during treatment.
Check for the model name 'IcePearl 2.1 CX' and batch numbers listed in the recall: A1564, A1521, A6723, A6908, A6929, A7015, T0025, T0056, T0137, T0138, T0269, U0041.
Review the batch numbers and model codes on the needle to confirm if it is affected by this recall.
The needle surface can deteriorate due to unexpected electrolysis during procedures, which may cause complications.
The recall does not specify a remedy, so check the product details to see if it is affected and contact Boston Scientific for further instructions.
Yes, affected batch numbers include A1564, A1521, A6723, A6908, A6929, A7015, T0025, T0056, T0137, T0138, T0269, U0041.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2676-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2676-2020 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.
