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Recall Observatory FDA recall evidence

Device product

IceRod" i-Thaw" Prostate Cryoablation Kit

Z-0691-2021

November 18, 2020

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 86777
Status
Completed
Classification
Class II
Quantity
243 units
Official record key
device-enforcement:Z-0691-2021

Official wording

Reason: Complaint trend regarding needle shaft gas leaks.

Code information: UPN: FPRPR4070 UDIs: 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830105 Batch Numbers: U1363, U0865, U0555, U0542, U0151, U0150, U0054, U0053, U0046, U0037, U0036, T0633, T0515, T0430, T0274, T0273, T0201, T0188, T0167, A7174, A7100, A7044, A7022, A7021, A6788, A6740, A2117, A2019, A1968, A1753, A1605, A1535, A1430, A1429, A1235, U1262, U1114, U1036, U0910, U0909, U0863, U0365, U0280, U0281, U0180, U0088, U0038, T0529, T0457, T0235, T0178, T0058, A6911, A6835, A6695, A6648, A2133, A2040, A2033, A1889, A1634, A1368, A1225, G5063, G5871, G5900, G5902, G5975, P1901

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Complaint trend regarding needle shaft gas leaks.