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

Recall Z-2053-2017 — HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.

U.S. FDA — Device Enforcement · United States · 2017-03-30 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2053-2017
Date of alert: 2017-03-30
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Thoratec Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00813024011286

Reported risk: St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.

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.

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.

Recall Z-2053-2017 — HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.

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