HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Reported: June 29, 2022 Initiated: May 5, 2022 #Z-1266-2022
Product Description
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Reason for Recall
Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and no longer provide power or prevent the battery from holding a complete charge or properly recharging.
Details
- Recalling Firm
- Medtronic Inc
- Units Affected
- 429 batteries
- Distribution
- Worldwide Distribution. US nationwide, Austria, Belgium, Finland, France, Germany, Hungary, Italy, Netherlands, New Zealand, North Macedonia, Norway, Poland, Spain, Switzerland, and the United Kingdom.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.. Recalled by Medtronic Inc. Units affected: 429 batteries.
Why was this product recalled? ▼
Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and no longer provide power or prevent the battery from holding a complete charge or properly recharging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 29, 2022. Severity: Critical. Recall number: Z-1266-2022.
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