Device product

IceSeed" Prostate Cryoablation Kit

Z-0687-2021

November 18, 2020

Class II

Product summary

Firm: Boston Scientific Corporation
Event: Event 86777
Status: Completed
Classification: Class II
Quantity: 52 units
Official record key: device-enforcement:Z-0687-2021

Official wording

Reason: Complaint trend regarding needle shaft gas leaks.

Code information: UPN: FPRPR3008 UDIs: 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068 Batch Numbers: T0783, T0686, T0719, T0678, A6713, A6676, A2130, A2075, A1813, A1695, A1684

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Complaint trend regarding needle shaft gas leaks.