Boston Scientific recalls IceSeed 1.5mm MRI cryoablation needles with reported gas leaks. Affected units have specific batch numbers and UDIs. Consumers should stop using if they own the recalled model.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IceSeed 1.5mm MRI cryoablation needles due to reported gas leaks in the needle shaft. This could potentially cause complications during medical procedures if the device fails under pressure.
The needle shaft may leak gas during use, which could lead to complications if the device fails under pressure during a medical procedure. This is a reported issue but not confirmed to cause injuries.
Patients using this specific cryoablation needle for medical procedures are most at risk. The recall affects medical devices sold to hospitals and clinics.
Check for batch numbers: U1368, U1367, U1040, U0396, U0380, U0375, U0374, U0242, U0241, T0532, T0533, T0531, T0530, T0444, T0443, T0442, T0353, T0354, T0262, T0263, A6720, A6719, A6698, A6697, A2049, A2050, A1999, A1998, A1990, A1991, A1891, A1890, A1844, A1845, A1690, A1562, A1563, A1533, A1326, A1325, A1197, A1196, A1041, A1040, A1008, A1007, A0955, A0954. The device has a unique identifier (UDI) starting with 7290104830280.
Identify your needle's batch number and unique device identifier (UDI) to confirm if it's affected.
Boston Scientific is recalling these needles due to reported gas leaks in the needle shaft, which could potentially cause complications during medical procedures.
Check the batch numbers listed: U1368, U1367, U1040, U0396, U0380, U0375, U0374, U0242, U0241, T0532, T0533, T0531, T0530, T0444, T0443, T0442, T0353, T0354, T0262, T0263, A6720, A6719, A6698, A6697, A2049, A2050, A1999, A1998, A1990, A1991, A1891, A1890, A1844, A1845, A1690, A1562, A1563, A1533, A1326, A1325, A1197, A1196, A1041, A1040, A1008, A1007, A0955, A0954. The device has a unique identifier (UDI) starting with 7290104830280.
The recall does not specify a remedy, so contact Boston Scientific directly for guidance on next steps.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0680-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0680-2021 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.
