Heartware Medtronic HVAD System Recalled for Transient Electrical Interruptions
Heartware is recalling HVAD System components due to possible transient electrical connection interruptions that may cause unexpected beeping or power switching.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low risk of adverse health consequences. The hazard involves transient electrical interruptions and beeping, with no reported injuries or deaths in the source text.
Plain-English summary
Heartware is recalling specific components of the Medtronic HVAD System, including Controllers, DC Adapters, AC Adapters, and Battery Packs. The recall involves 175,878 devices distributed worldwide, including in the United States and numerous international locations.
The recall is due to a possible transient electrical connection interruption between the power source and the Controller. This interruption, typically lasting 1-2 seconds, is caused by oxidation between the power source connector and socket. It may result in unintended switching to the secondary power source and/or unexpected audible tones (beeping).
Patients using the HVAD System should contact their healthcare provider or Heartware for instructions on how to address the potential connection issue.
The recalled product
- Product
- Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420 (b) DC Adapter, Product numbers: 1435, 1440 (c) AC Adapter, Product numbers: 1425, 1430 (d) Battery Pack, Product
- Manufacturer
- Heartware
- Affected units
- 175,878
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 (20)
- 00888707000475 1407: '00888707000291
- '00888707000727
- '00888707000710
- 00888707000734
- '00888707000741
- '00888707000765
- '00888707000758
- '00888707000789
- '00888707000772
- '00888707000499
- '00888707000796
- '00888707000802
- '00888707000819
- '00888707000482
- '00888707004534
- '0888707001670
- '00888707001656
- '00888707001663
- '00888707001670
- '00888707001687
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Heartware
See all →- HighHeartware Recalls HVAD System Controllers for Exchange
FDA (Devices) · 2017-05-03
- ModerateHeartWare HVAD Pump Driveline Splice Kit Recall for Improved Repair
FDA (Devices) · 2017-05-03
Other medical device recalls
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighMedline Recalls 71 Convenience Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02
- HighMedline Recalls 419 Surgical Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02