Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0507-2026 — Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, EU Software Version: N/A Product Description: The HeartMate II LVAS is an a

U.S. FDA — Device Enforcement · United States · 2025-10-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0507-2026
Date of alert
2025-10-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Thoratec LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00813024011224
Reported risk: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.