Home / Recalls / Boston Scientific Corporation / Z-0669-2021

Z-0669-2021 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
26 units

Product Description

IceRod" 1.5 Cryoablation Needle

Reason for Recall

Complaint trend regarding needle shaft gas leaks.

Distribution Pattern

Nationwide

Code Information

UPN: FPRPR3203 UDIs: 07290104830198, 07290104830198, 07290104830198, 07290104830198 Batch Numbers: U0382, A6775, A1875, A0575

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