Boston Scientific recalls IceSeed 1.5 MRI Cryoablation Needles with reported gas leaks. Affected units have specific batch numbers and UDIs. Consumers should check their device details to determine if recalled.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IceSeed 1.5 MRI Cryoablation Needles due to reported gas leaks in the needle shaft. This could potentially cause issues during medical procedures if the device fails unexpectedly.
The needle shaft has been reported to leak gas, which could lead to unexpected device failure during medical procedures. This might cause complications if the device malfunctions while being used in a patient.
Medical professionals using the IceSeed 1.5 MRI Cryoablation Needle for procedures are most at risk. Patients receiving the device for cryoablation treatments may also be affected.
Check the product's batch numbers: U1438, U1439, U0962, U0961, U0437, U0378, T0697, T0688, T0388, T0387, A7150, A7149, A2018, A2017, A1711, A1710, A1689, A1403, A1404, A0896, A0897. Also look for the unique device identifier (UDI) numbers: 7290104830266.
Review the batch numbers and unique device identifiers (UDIs) on your IceSeed 1.5 MRI Cryoablation Needle to see if it matches the recalled units.
The recall is based on reported gas leaks in the needle shaft, but the hazard is described as a complaint trend, not a confirmed risk of serious injury. The danger level is low risk.
Check the batch numbers listed: U1438, U1439, U0962, U0961, U0437, U0378, T0697, T0688, T0388, T0387, A7150, A7149, A2018, A2017, A1711, A1710, A1689, A1403, A1404, A0896, A0897. Also look for the unique device identifier (UDI) number 7290104830266.
The recall does not specify a remedy, so there is no action required beyond checking if your device is affected.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0681-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0681-2021 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.
