Device product

IcePearl" 2.1 CX L 90¿ Cryoablation Needle

Z-0662-2021

November 18, 2020

Class II

Product summary

Firm: Boston Scientific Corporation
Event: Event 86777
Status: Completed
Classification: Class II
Quantity: 261 units
Official record key: device-enforcement:Z-0662-2021

Official wording

Reason: Complaint trend regarding needle shaft gas leaks.

Code information: UPN: FPRPR3617 UDIs: 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072 Batch numbers: U1310, U1309, U1306, U1305, X0828, U0727, U0728, U0641, U0640, U0587, U0586, U0585, U0084, A7113, A6977, A6963, A6962, A6681, A6682, A1657, A1522, A1178, A1177

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Complaint trend regarding needle shaft gas leaks.