Home / Recalls / Boston Scientific Corporation / Z-0676-2021

Z-0676-2021 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: 152 units

Product Description

IceSeed" 1.5 Cryoablation Needle

Reason for Recall

Complaint trend regarding needle shaft gas leaks.

Distribution Pattern

Nationwide

Code Information

UPN: FPRPR3201 UDIs: 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181 Batch Numbers: U0181, T0393, A6912, A6664, A1915, A1072, A1024, A0853, A0574

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