Z-0067-2019 Class II Terminated
FDA device recall Z-0067-2019 was initiated by Heartware, Inc. on Aug 28, 2018 and is designated Class II. Reason for recall: Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid ingress, specifically they may have the potential to develop hairline cracks at the power… The recall status is terminated (terminated Apr 5, 2019). Affected quantity: 17,275 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 10, 2018
- Initiation Date
- Aug 28, 2018
- Termination Date
- Apr 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,275 units
Product Description
Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
Reason for Recall
Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid ingress, specifically they may have the potential to develop hairline cracks at the power ports of the controller housing.
Distribution Pattern
Worldwide Distribution
Code Information
Serial number range: CON300175 - CON320540
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0067-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026