Home / Recalls / Boston Scientific Corporation / Z-0667-2021

Z-0667-2021 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
255 units

Product Description

IceRod" 1.5 PLUS Cryoablation Needle

Reason for Recall

Complaint trend regarding needle shaft gas leaks.

Distribution Pattern

Nationwide

Code Information

UPN: FPRPR3510 UDIs: 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570 Batch Numbers: U1021, U1022, U1014, U1013, U0780, U0781, U0391, U0214, U0008, A2081, A2080, A1531

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