HeartWare HVAD Pump Recalled for Foreign Material in Driveline Connector
HeartWare is recalling 344 HVAD pumps worldwide because foreign material in the driveline connector could cause electrical faults.
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 classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
HeartWare, Inc. is recalling 344 HeartWare Ventricular Assist System (HVAD) pumps, including US Model No. 1103 and International Model No. 1104XX. The recall affects all sterile un-implanted stock manufactured prior to HW25838. These devices are used as a bridge-to-cardiac transplantation for patients with refractory end-stage left ventricular heart failure.
The recall is due to foreign material found within the driveline connector of the HVAD Pump. This material could cause increased impedance, resulting in electrical faults. The affected units were distributed worldwide, including in the United States and numerous international locations.
Healthcare providers and patients should contact HeartWare, Inc. for instructions on removing the affected pumps from service. No specific instructions for immediate patient action are provided in the source text beyond the removal of un-implanted stock.
The recalled product
- Product
- HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart…
- Manufacturer
- HeartWare, Inc
- Category
- Medical Device — Cardiovascular
- Affected units
- 344
Distribution
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