Boston Scientific recalls specific cryoablation needles for possible surface deterioration during procedures. Affected models include IcePearl 2.0 CX 90 and Galil Medicals 2.1 CX. No remedy is stated in the recall notice.
The needle surface deteriorated due to unexpected electrolysis during procedure.
Boston Scientific is recalling certain cryoablation needles that may have surface deterioration during surgical procedures. This could lead to potential complications if used improperly. The recall affects specific batch numbers and model types used in medical procedures.
The needle surface deteriorates due to unexpected electrolysis during procedures, which could lead to potential complications such as tissue damage or improper treatment outcomes. This issue occurs during cryoablation surgeries where the needles are used to destroy tissue.
Medical professionals using the recalled cryoablation needles for surgical procedures are most at risk. Patients undergoing treatments with these needles may be affected if the needles are used without proper safety checks.
Check for the product names: IcePearl 2.0 CX 90 Cryoablation Needle or Galil Medicals 2.1 CX Cryoablation Needle. Look for batch numbers listed in the recall (e.g., A0735, A0736, etc.) or the specific batch numbers mentioned in the recall notice.
Identify the product name and batch numbers to confirm if your needle is affected by this recall.
The needle surface deteriorates due to unexpected electrolysis during procedures, which could lead to potential complications.
The recall notice does not specify any remedy or action steps. Check product details to see if your needle is affected.
Affected batch numbers include A0735, A0736, A0749, A0750, and many others as 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-2674-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2674-2020 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.
