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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Possible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the Controller, while the power source is connected, that may cause unintended switching to the secondary…"
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…
- 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.
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