Heartware Recalls HVAD System Controllers for Exchange
Heartware is recalling all HVAD System Controllers currently on the market to exchange them for the next generation HVAD Controller (Controller 2.0).
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: "Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0)"
Plain-English summary
Heartware is recalling all HeartWare HVAD System Controllers currently on the market. The recall involves the exchange of these units for the next generation HVAD Controller (Controller 2.0).
The HeartWare Ventricular Assist System (VAS) is indicated for use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The system is designed for in-hospital and out-of-hospital settings, including transportation via fixed-wing aircraft or helicopter.
The recall affects 8,343 units in the US and 13,145 units internationally. Affected product numbers include 1401US, 1401XX, 1403US, 1407XX, and 1400 with serial numbers lower than CON300000. The HeartWare HVAD DC Adapter (Product number 1435) is also listed in the code information. The source text does not specify a particular hazard or injury associated with the recall.
The recalled product
- Product
- HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System…
- Manufacturer
- Heartware
- Category
- Medical Device — Cardiovascular
- Hazard
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 (4)
- HeartWare HVAD System Controller Product numbers: 1401US
- 1401XX
- 1403US
- 1407XX
Distribution
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