Home / Recalls / Boston Scientific Corporation / Z-0673-2021

Z-0673-2021 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
92 units

Product Description

IceSphere" 1.5 90¿ Cryoablation Needle

Reason for Recall

Complaint trend regarding needle shaft gas leaks.

Distribution Pattern

Nationwide

Code Information

UPN: FPRPR3260 UDIs: 07290104830259, 07290104830259, 07290104830259, 07290104830259, 07290104830259, 07290104830259 Batch Numbers: U0326, U0325, U0286, U0285, A7012, A7011

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