Boston Scientific recalls IceSeed 1.5 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 IceSeed 1.5 90° Cryoablation Needles due to reported gas leaks in the needle shaft. This could potentially cause issues during medical procedures, though the recall does not specify serious injury risks.
The needle shaft has been reported to leak gas, which could affect the device's performance during medical procedures. However, the recall does not indicate a risk of serious injury or death in normal use.
Medical professionals using the IceSeed needle for cryoablation procedures are most likely affected. Patients using this device for treatment may also be impacted if they have the recalled model.
Check the product's batch numbers: U1165, U1166, U0911, U0912, U0397, U0381, U0368, T0791, T0790, T0465, T0464, T0050, T0051, A6981, A6980, A2129, A2128, A1635, A1636, A1528, A1392, A1391, A0944, A0943, A0408, A0407, A0284. Also look for the unique device identifiers (UDIs): 7290104830235.
Review the batch numbers and unique device identifiers (UDIs) on your IceSeed needle to see if it matches the recalled units.
The recall reports gas leaks in the needle shaft but does not specify a risk of serious injury or death in normal use. This is considered a low-risk issue.
Check the batch numbers listed: U1165, U1166, U0911, U0912, U0397, U0381, U0368, T0791, T0790, T0465, T0464, T0050, T0051, A6981, A6980, A2129, A2128, A1635, A1636, A1528, A1392, A1391, A0944, A0943, A0408, A0407, A0284. Also check the unique device identifier (UDI): 7290104830235.
The recall does not provide specific action steps beyond checking if your product is affected. Contact Boston Scientific directly for further 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-0675-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0675-2021 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.
