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).
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a critical life-support medical device (ventricular assist system) where the source text does not explicitly state that no injuries or illnesses have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
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 (VAS)
- 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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