Home / Recalls / Boston Scientific Corporation / Z-0693-2021

Z-0693-2021 Class II

Recalled by Boston Scientific Corporation — Maple Grove, MN

FDA device recall Z-0693-2021 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: 115 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
115 units

Product Description

IceRod" He-Thaw Prostate Cryoablation Kit

Reason for Recall

Complaint trend regarding needle shaft gas leaks.

Distribution Pattern

Nationwide

Code Information

UPN: FPRPR4570 UDIs: 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830105, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099 Batch Numbers:G5063, G5871, G5900, G5902, G5975, P1901, P2150, P2204, P2206, P2207, P2240, P2241, P2242, P2243, P2245, P2247, P2249, P2251, P2253, P2254, P2256, P2258, P2259, P2261, P2262, P2263, P2268, P2272, P2274, P2404, P2405, P2406, P2411

Other recalls by Boston Scientific Corporation

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  • 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)

FDA data resources