Device product

IceRod" Prostate Cryoablation Kit

Z-0688-2021

November 18, 2020

Class II

Product summary

Firm: Boston Scientific Corporation
Event: Event 86777
Status: Completed
Classification: Class II
Quantity: 64 units
Official record key: device-enforcement:Z-0688-2021

Official wording

Reason: Complaint trend regarding needle shaft gas leaks.

Code information: UPN: FPRPR3070 UDIs: 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082 Batch Numbers: U0412, U0029, U0039, T0775, T0687, T0675, A1873, A1866, A1820, A1643, A1420, A1226

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Complaint trend regarding needle shaft gas leaks.