Boston Scientific recalls IcePearl 2.1 CX Prostate Kit Visual Ice System for potential needle surface deterioration during procedures. Affected units include specific batch numbers and model codes. Contact for remedy details.
The needle surface deteriorated due to unexpected electrolysis during procedure.
Boston Scientific is recalling its IcePearl 2.1 CX Prostate Kit Visual Ice System due to a risk that the needle surface may deteriorate during procedures. This could lead to complications during cryoablation surgeries if not addressed.
The needle surface may deteriorate due to unexpected electrolysis during surgical procedures. This could potentially cause complications during cryoablation treatments if the needle fails under use.
Surgical patients and medical professionals using the IcePearl 2.1 CX Prostate Kit Visual Ice System for cryoablation procedures. Those with specific batch numbers listed in the recall are most at risk.
Check for the product name 'IcePearl 2.1 CX Prostate Kit Visual Ice System' and specific batch numbers listed in the recall (e.g., A1148, A1171, A1248). The product is prescription-only and sold through medical channels.
Identify the batch numbers listed in the recall (e.g., A1148, A1171, A1248) to confirm if your unit is affected.
The recall indicates a potential risk of needle surface deterioration during procedures, so affected units should not be used until the remedy is applied.
Check the batch numbers listed in the recall to determine if your unit is affected. If affected, contact Boston Scientific for further instructions.
The recall record does not specify a remedy, so contact Boston Scientific directly for assistance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2679-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2679-2020 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.
