Home / Recalls / Boston Scientific Corporation / Z-0674-2021

Z-0674-2021 Class II

Recalled by Boston Scientific Corporation — Maple Grove, MN

FDA device recall Z-0674-2021 was initiated by Boston Scientific Corporation on November 18, 2020 and is designated Class II. Reason for recall: Complaint trend regarding needle shaft gas leaks. Affected quantity: 39 units.

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: 39 units

Product Description

IceSphere" 1.5 Cryoablation Needle

Reason for Recall

Complaint trend regarding needle shaft gas leaks.

Distribution Pattern

Nationwide

Code Information

UPN: FPRPR3258 UDI: 07290104830211 Batch Number: A0125

Other recalls by Boston Scientific Corporation

Z-2725-2026 Class II — Rapid Refill Continuous Injection System, UPN M00566001 (June 30, 2026)
Z-2839-2026 Class II — Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and U (June 30, 2026)
Z-2838-2026 Class II — Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions an (June 30, 2026)
Z-2840-2026 Class II — Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: (June 30, 2026)
Z-2771-2026 Class II — Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M001395 (June 19, 2026)
Z-2752-2026 Class II — FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation (June 11, 2026)
Z-2750-2026 Class II — FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M4 (June 11, 2026)
Z-2755-2026 Class II — FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature a (June 11, 2026)
Z-2753-2026 Class II — FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M4 (June 11, 2026)
Z-2754-2026 Class II — FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculatu (June 11, 2026)