Recall Z-1266-2022— Medtronic Inc
Class I · Ongoing
Class I FDA medical device recall by Medtronic Inc, initiated 2022-05-05. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.. Reason: 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..
- Recalling firm
- Medtronic Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2022-05-05
- Firm location
- Minneapolis, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.