HVAD Ventricular Assist Device Updated Instructions for Alarm Conditions
Heartware is providing updated instructions for the HVAD ventricular assist device to clarify Controller Fault alarm conditions and device useful life information for 892 implanted units worldwide.
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 HVAD is a life-critical implanted ventricular assist device. Clarification of alarm conditions and device useful life is a risk-of-harm issue for patients who depend on proper alarm interpretation and device maintenance. No injuries or illnesses have been reported, but the scope (892 devices worldwide) and critical nature of alarm understanding in cardiac support devices warrant a High severity rating.
Plain-English summary
Heartware, Inc. is providing updated documentation for the HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102. Updated instructions for use (IFU) and patient manual (PM) will clarify the conditions under which an HVAD Controller Fault alarm may sound and recommended troubleshooting actions. The updates will also address instructions relating to the useful life of HVAD system components.
Approximately 892 units of this device have been distributed worldwide. Healthcare providers and patients with an HVAD device should obtain and review the updated documentation when it becomes available from Heartware.
The updated instructions are intended to ensure proper interpretation of Controller Fault alarms and understanding of device component maintenance and replacement requirements.
The recalled product
- Product
- HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
- Manufacturer
- Heartware, Inc.
- Hazard
- controller-fault-alarm
- device-lifespan-instruction
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 (20)
- Serial numbers: HW1000
- HW1001
- HW1002
- HW1003
- HW1006
- HW1007
- HW1008
- HW1010
- HW1011
- HW1013
- HW1017
- HW1018
- HW1019
- HW1026
- HW1027
- HW1029
- HW1030
- HW1034
- HW1035
- HW1037
Distribution
Distribution scope not specified by the agency.
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