Boston Scientific recalls IcePearl 2.1 CX L 90° Cryoablation Needles with reported gas leaks. Affected units have specific batch numbers and UDIs. Consumers should check their product details to determine if recalled.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IcePearl 2.1 CX L 90° Cryoablation Needles due to reported gas leaks in the needle shaft. This could potentially cause issues during medical procedures if the needle leaks gas.
The needle shaft may leak gas, which could cause issues during medical procedures. This is a complaint trend reported by users, but no specific injuries have been reported.
Medical professionals using the IcePearl 2.1 CX L 90° Cryoablation Needle for procedures. Patients receiving this device are at risk if the needle leaks gas during treatment.
Check for batch numbers: U1310, U1309, U1306, U1305, X0828, U0727, U0728, U0641, U0640, U0587, U0586, U0585, U0084, A7113, A6977, A6963, A6962, A6681, A6682, A1657, A1522, A1178, A1177. Also look for Unique Device Identifiers (UDIs): 7290104831072.
Review your IcePearl 2.1 CX L 90° Cryoablation Needle's batch number and Unique Device Identifier (UDI) to see if it matches the recalled units.
No injuries have been reported as of the recall announcement.
Check the batch number on the needle and the Unique Device Identifier (UDI) listed in the recall notice.
The recall does not specify a remedy, so contact Boston Scientific directly 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-0662-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0662-2021 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.
