HeartWare HVAD Pump Recalled for Foreign Material in Driveline Connector

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 failu

Manufacturer

HeartWare, Inc

Category

Medical Device — Cardiovascular

Hazard

• electrical-fault
• foreign-material

Affected units

344

Distribution

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