Boston Scientific recalls IcePearl 2.1 CX 90° Cryoablation Needles with reported gas leaks. Affected units have specific batch numbers and UDIs. Stop using if you own one.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IcePearl 2.1 CX 90° Cryoablation Needles due to reported needle shaft gas leaks. This could lead to potential safety issues during medical procedures. Affected units have specific batch numbers and unique device identifiers.
The needle shaft may leak gas during use, which could cause unintended pressure changes in the medical procedure. This might lead to complications such as tissue damage or procedural errors.
Medical professionals using the IcePearl 2.1 CX 90° Cryoablation Needles for procedures are most at risk. Patients using these needles for treatment may also be affected.
Check for the product name 'IcePearl 2.1 CX 90° Cryoablation Needle' with batch numbers listed in the recall (e.g., U1391, U1389, etc.) or unique device identifiers (UDIs) starting with 7290104830990.
Look for the product name 'IcePearl 2.1 CX 90° Cryoablation Needle' and batch numbers listed in the recall (e.g., U1391, U1389, etc.) or unique device identifiers (UDIs) starting with 7290104830990.
The recalled product is the IcePearl 2.1 CX 90° Cryoablation Needle.
Check for the product name 'IcePearl 2.1 CX 90° Cryoablation Needle' and batch numbers listed in the recall (e.g., U1391, U1389, etc.) or unique device identifiers (UDIs) starting with 7290104830990.
The recall does not specify a remedy, so contact Boston Scientific directly for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0660-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0660-2021 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.
