Device product

IceFORCE" 2.1 CX Cryoablation Needle

Z-0658-2021

November 18, 2020

Class II

Product summary

Firm: Boston Scientific Corporation
Event: Event 86777
Status: Completed
Classification: Class II
Quantity: 75 units
Official record key: device-enforcement:Z-0658-2021

Official wording

Reason: Complaint trend regarding needle shaft gas leaks.

Code information: UPN: FPRPR3604 UDIs: 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027 Batch Numbers: U0903, U0785, U0617, U0042, T0166, T0156, A7083, A6931, A6928, A6916, A6734, A1549, A1527, X1483, A1203

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Complaint trend regarding needle shaft gas leaks.