Z-0668-2021 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
93 units

Product Description

IceRod" 1.5 90¿ Cryoablation Needle

Reason for Recall

Complaint trend regarding needle shaft gas leaks.

Distribution Pattern

Nationwide

Code Information

UPN: FPRPR3204 UDIs: 7290104830242, 7290104830242, 7290104830242, 7290104830242, 7290104830242, 7290104830242, 7290104830242 Batch Numbers: U0495, U0498, U0496, U0497, U0420, A0902, A0903