Boston Scientific recalls IceSeed Prostate Cryoablation Kit units with reported needle shaft gas leaks. Affected units have specific batch numbers and UDIs. Stop using immediately if you own the recalled model.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IceSeed Prostate Cryoablation Kits due to reported needle shaft gas leaks. This could pose a risk during medical procedures, though the exact harm isn't specified in the recall notice.
The recall mentions 'complaint trend regarding needle shaft gas leaks,' but does not specify how these leaks could cause harm during medical procedures. The exact risk mechanism is unclear from the record.
Patients undergoing prostate cryoablation procedures who use the recalled IceSeed kits are affected. Medical professionals using the kits for this procedure are at risk if they have the recalled models.
Check for batch numbers T0783, T0686, T0719, T0678, A6713, A6676, A2130, A2075, A1813, A1695, or A1684 on the kit. Also look for unique device identifiers (UDIs) starting with 7290104830068.
If you have the recalled IceSeed Prostate Cryoablation Kit, stop using it right away to avoid potential risks.
The recall is due to a complaint trend regarding needle shaft gas leaks, but the exact risk is not specified in the notice.
Check for batch numbers T0783, T0686, T0719, T0678, A6713, A6676, A2130, A2075, A1813, A1695, or A1684, or unique device identifiers (UDIs) starting with 7290104830068.
Stop using it immediately and contact Boston Scientific 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-0687-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0687-2021 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.
