HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Reported: August 24, 2022 Initiated: June 28, 2022 #Z-1512-2022
Product Description
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Reason for Recall
Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging.
Details
- Recalling Firm
- Heartware, Inc.
- Units Affected
- 19616 batteries
- Distribution
- Worldwide distribution. US nationwide, Japan, Indonesia, Brazil, Chile, Belgium, Italy, Germany, Switzerland, United Kingdom, Poland, Hungary, Czech Republic, Mauritius, France, South Africa, Greece, Netherlands, Sweden, Norway, Denmark, Estonia, Lebanon, Croatia, Spain, Austria, United Arab Emirates, Luxembourg, Canada, Korea, Republic Of, Israel, Qatar, India, Australia, New Zealand, Taiwan, Malaysia, Hong Kong, Singapore, Latvia, Saudi Arabia, Slovakia, North Macedonia, Finland, Turkey, Armenia, Colombia, Kazakhstan, Kuwait, Serbia, Bahrain, Egypt, Pakistan, and Ukraine.
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE. Recalled by Heartware, Inc.. Units affected: 19616 batteries.
Why was this product recalled? ▼
Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 24, 2022. Severity: Critical. Recall number: Z-1512-2022.
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