Heartware HVAD Pump Accessories Recalled Over Increased Mortality and Device Failures
Heartware is recalling HVAD Pump Accessories due to clinical data showing higher rates of neurological adverse events and mortality compared to other left ventricular assist devices, and reports of pump malfunctions.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I recalls score at least 4. The mention of mortality associated with the device from observational clinical data, combined with serious neurological adverse events and pump failure risks in a critical life-sustaining device, meets the rubric criterion for Critical (5).
Plain-English summary
Heartware, Inc. is recalling HeartWare HVAD Pump Accessories (Reference MCS1753AK) worldwide. The recall involves 76 units distributed to the United States and over 30 countries.
The recall is due to observational clinical data showing higher rates of neurological adverse events and mortality with the HVAD system compared to other left ventricular assist devices. Heartware has also received reports that the internal pump may delay or fail to restart, which could affect device function.
The HVAD is a critical device used to support heart function in patients with advanced heart failure. Patients with this device should contact their healthcare provider or Heartware immediately for guidance.
The recalled product
- Product
- HeartWare HVAD Pump Accessories, REF MCS1753AK
- Manufacturer
- Heartware, Inc.
- Hazard
- neurological-events
- mortality
- device-failure
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 (2)
- GTIN: 00888707005371
- 00888707007597 All serial numbers
Distribution
Distributed nationwide across the United States.
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