HeartWare Ventricular Assist System Recalled for Power Switching Issues
HeartWare Inc. is recalling HVAD systems due to abnormal power source switching. The device is used as a bridge to cardiac transplantation.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The device is used for patients at risk of death from end-stage heart failure, and a power source switching defect in such a critical life-support device poses a significant risk of serious injury or death, meeting the criteria for a Severe rating.
Plain-English summary
HeartWare Inc. is recalling the HeartWare Ventricular Assist System (HVAD) because of complaints regarding abnormal power source switching. The HVAD is a medical device used as a bridge to cardiac transplantation for patients at risk of death from refractory end-stage left ventricular heart failure.
The recall affects 3,747 units currently in use. These devices were distributed across the United States and internationally to numerous countries, including Argentina, Australia, Canada, Germany, Japan, and the United Kingdom. The affected catalog numbers are 1101 and 1103 for the US, and 1100, 1101, 1102, 1104, 1104JP, and 1205 for other regions. All serial numbers of HVAD systems currently in use are included in this recall.
Patients using the HVAD system should contact their healthcare provider or HeartWare Inc. for further instructions regarding the abnormal power source switching issue.
The recalled product
- Product
- HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
- Manufacturer
- HeartWare Inc
- Category
- Medical Device — Cardiovascular
- Affected units
- 3,747
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Catalog #'s US: 1101 and 1103 / OUS: 1100
- 1101
- 1102
- 1104
- 1104JP and 1205. Serial #: ALL HeartWare HVAD systems currently in use.
Distribution
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