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Recall Observatory FDA recall evidence

Device product

IceRod" He-Thaw Prostate Cryoablation Kit

Z-0693-2021

November 18, 2020

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 86777
Status
Completed
Classification
Class II
Quantity
115 units
Official record key
device-enforcement:Z-0693-2021

Official wording

Reason: Complaint trend regarding needle shaft gas leaks.

Code information: UPN: FPRPR4570 UDIs: 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830105, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099 Batch Numbers:G5063, G5871, G5900, G5902, G5975, P1901, P2150, P2204, P2206, P2207, P2240, P2241, P2242, P2243, P2245, P2247, P2249, P2251, P2253, P2254, P2256, P2258, P2259, P2261, P2262, P2263, P2268, P2272, P2274, P2404, P2405, P2406, P2411

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Complaint trend regarding needle shaft gas leaks.