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Recall Observatory FDA recall evidence

Device product

IceSeed" 1.5¿ MRI 90¿ Cryoablation Needle ¿

Z-0680-2021

November 18, 2020

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 86777
Status
Completed
Classification
Class II
Quantity
1,526 units
Official record key
device-enforcement:Z-0680-2021

Official wording

Reason: Complaint trend regarding needle shaft gas leaks.

Code information: UPN: FPRPR3194 UDIs: 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280 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

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Complaint trend regarding needle shaft gas leaks.