Boston Scientific recalls prescription-only cryoablation needles for potential surface deterioration during procedures. Affected models include Galil Medicals 2.1 CX with specific batch numbers. No remedy details provided in recall notice.
The needle surface deteriorated due to unexpected electrolysis during procedure.
Boston Scientific is recalling prescription-only cryoablation needles that may have deteriorated needle surfaces during procedures due to unexpected electrolysis. This could lead to complications during surgery if the needles are used without proper condition.
The needles may develop surface deterioration during procedures due to unexpected electrolysis. This could cause the needle to become unstable or malfunction during surgery, potentially leading to tissue damage or procedural complications.
Surgical professionals using the recalled needles for cryoablation procedures are most at risk. Patients undergoing surgery with these needles may face complications from needle surface deterioration.
Check for the product name 'Galil Medicals 2.1 CX Cryoablation Needles' with specific batch numbers listed in the recall notice. The recall covers prescription-only use and includes batch numbers starting with X and A.
Identify the batch numbers listed in the recall notice to determine if your needles are affected.
The recall indicates potential surface deterioration during procedures due to unexpected electrolysis, so they should not be used until the recall is addressed.
Affected batch numbers include X2073, X6812, A0815, A0994, A1044, A1046, A1188, A1189, A1544, A1545, A1774, A1775, A2029, A2030, A6677, A6678, A7032, A7033, A7082, T0134, T0135, T0142, T0143, T0275, T0278, U0160, U0161.
The recall notice does not specify a remedy, so affected users should contact Boston Scientific for further instructions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2683-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2683-2020 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.
