Home / Recalls / Boston Scientific Corporation / Z-0684-2021

Z-0684-2021 Class II

Recalled by Boston Scientific Corporation — Maple Grove, MN

FDA device recall Z-0684-2021 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: 140 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
140 units

Product Description

Three IceFORCE" 2.1 CX Prostate Cryoablation Kit

Reason for Recall

Complaint trend regarding needle shaft gas leaks.

Distribution Pattern

Nationwide

Code Information

UPN: FPRPR3607 UDIs: 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058 Batch Numbers: U1302, U1303, U1301, U1032, U0616, U0590, U0589, U0583, U0540, U0363, U0318, U0083, T0552, T0163, T0154, A6915, A6849, A6848, A6757, A6754, A1782, A1569, A1567, A1436, A1298, A1194

Other recalls by Boston Scientific Corporation

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  • 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)

FDA data resources