Boston Scientific recalls IceFORCE 2.1 CX 90° Cryoablation Needles with potential gas leaks. Affected units have specific batch numbers. Stop using immediately to prevent risks.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IceFORCE 2.1 CX 90° Cryoablation Needles due to reported gas leaks in the needle shaft. This could lead to improper medical procedures if the device fails during use. Affected units have specific batch numbers listed in the recall.
The needle shaft has been reported to leak gas, which could cause the device to malfunction during medical procedures. This might lead to incomplete treatment or other complications, but the risk of serious injury is not clearly described in the recall.
Medical professionals who use these needles for cryoablation procedures are most at risk. Patients using the recalled needles during treatment may also be affected if the device malfunctions.
Check the batch numbers listed in the recall: U1397, U1395, U1359, U1357, and other specific batch codes. The product is a cryoablation needle used in medical procedures.
Look for batch numbers on the needle packaging or device itself. Affected units have specific batch numbers listed in the recall.
Boston Scientific is recalling these needles due to reported gas leaks in the needle shaft, which could cause the device to malfunction during medical procedures.
Check the batch numbers on the needle. Affected units have specific batch numbers listed in the recall, such as U1397, U1395, U1359, and others.
The recall does not specify a stop-use instruction. However, it's recommended to check the batch numbers and contact Boston Scientific if you have a needle with a listed batch number.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0657-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0657-2021 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.
