Device product

Five IceRod" i-Thaw" Prostate Cryoablation Kit

Z-0690-2021

November 18, 2020

Class II

Product summary

Firm: Boston Scientific Corporation
Event: Event 86777
Status: Completed
Classification: Class II
Quantity: 178 units
Official record key: device-enforcement:Z-0690-2021

Official wording

Reason: Complaint trend regarding needle shaft gas leaks.

Code information: UPN: FPRPR3571 UDIs: 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976 Batch Numbers: U1264, U1226, U1089, U1012, U1009, U0827, U0772, U0767, U0491, T0817, T0693, T0725, T0587, T0487, T0486, T0313, A7114, A6823, A2113, A1942, A1712, A1257, A1252

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Complaint trend regarding needle shaft gas leaks.