Heartware HVAD Pump Implant Kit Recalled for Driveline Connector Separation
HeartWare Inc is recalling HVAD Pump Implant Kits because the driveline connector housing may separate. This defect could affect patients using the device for heart failure.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
HeartWare Inc is recalling Heartware HVAD Pump Implant Kits, catalog numbers 1100 through 1104 and 1205. The recall involves 4,586 units distributed worldwide, including in the United States and numerous international countries.
The recall is due to a defect where the housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector. The device is used as a bridge-to-cardiac transplantation in patients at risk of death from refractory end-stage left ventricular heart failure.
Patients and healthcare providers should contact HeartWare Inc for instructions on how to proceed with the recall. The agency has classified this as a Class I recall.
The recalled product
- Product
- Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. 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…
- Manufacturer
- HeartWare Inc
- Affected units
- 4,586
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 (6)
- Catalog Numbers: 1100
- 1101
- 1102
- 1103
- 1104
- and 1205. Serial Numbers: HW001 to HW11270 and HW20001 to HW 20296.
Distribution
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Similar recalls
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