Boston Scientific recalls IceRod 1.5 MRI 90° 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 IceRod 1.5 MRI 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 a risk of injury.
The needles have reported gas leaks in the shaft, which could lead to improper cooling during medical procedures. However, the recall does not specify that this causes injury or serious harm in normal use.
Medical professionals using the IceRod needles for cryoablation procedures are likely affected. Patients receiving these procedures may be at risk if their device is recalled.
Check for the product name 'IceRod 1.5 MRI 90° Cryoablation Needle' with batch numbers listed in the recall (e.g., U1406, U1407, U1370) or unique device identifiers (UDIs) like 7290104830297.
Review your IceRod needle's batch number and unique device identifier (UDI) to see if it matches the listed affected units.
The recall mentions 'complaint trend regarding needle shaft gas leaks,' but does not specify that this causes injury or serious harm in normal use. The risk level is low.
Check the batch number (e.g., U1406, U1407) or unique device identifier (UDI) like 7290104830297 against the list provided in the recall.
The recall does not specify a remedy, so no action is required unless you find your device matches the affected batch numbers or UDIs.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0678-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0678-2021 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.
