Home / Recalls / Boston Scientific Corporation / Z-0661-2021

Z-0661-2021 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
86 units

Product Description

IcePearl" 2.1 CX Cryoablation Needle

Reason for Recall

Complaint trend regarding needle shaft gas leaks.

Distribution Pattern

Nationwide

Code Information

UPN: FPRPR3603 UDIs: 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010 Batch Numbers: U0902, U0786, U0646, U0558, U0041, T0269, T0137, T0138, T0056, T0025, A7015, A6929, A6908, A6723, A1564, A1521, A1249

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