Home / Recalls / Boston Scientific Corporation / Z-0683-2021

Z-0683-2021 Class II

Recalled by Boston Scientific Corporation — Maple Grove, MN

Recall Details

Product Type
Devices
Report Date
December 30, 2020
Initiation Date
November 18, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
215 units

Product Description

IcePearl" 2.1 CX Prostate Cryoablation Kit

Reason for Recall

Complaint trend regarding needle shaft gas leaks.

Distribution Pattern

Nationwide

Code Information

UPN: FPRPR3606 UDIs: 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041 Batch Numbers: U1473, U1299, U1300, U1261, U1213, U1109, U1039, U1031, U0925, U0924, U0858, U0784, U0614, U0613, U0582, U0554, U0226, U0227, U0093, U0027, U0082, T0592, T0437, T0268, T0237, T0236, T0224, T0141, T0136, T0054, A7148, A7088, A7026, A7013, A6925, A6856, A6743, A6702, A2121, A2118, A1936, A1582, A1561, A1460, A1248, A1171

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