HVAD Ventricular Assist Pump Model 1104CA: Instructions for Fault Alarm and Lifespan
Heartware recalls HVAD ventricular assist pump instructions to clarify controller fault alarm conditions and component useful life expectations.
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: FDA Class II recall of a critical life-sustaining cardiac device. The recall addresses potential confusion regarding controller fault alarm conditions and component useful life through instruction updates. No illnesses or injuries reported, but instruction ambiguities on a life-critical device present potential for patient harm.
Plain-English summary
Heartware, Inc. is recalling the HVAD (HeartWare Ventricular Assist Device) pump, Model 1104CA-CLIN (serial numbers HW24101, HW24102, HW24103, HW24104, HW24763, HW24755FSCA). Six units were distributed worldwide. This is a Class II medical device recall issued by the FDA.
The recall involves updates to the product's instructions for use (IFU) and patient manual. These updates will clarify the conditions under which the HVAD controller fault alarm may sound and provide recommended troubleshooting actions. The updates will also provide clarified instructions relating to the useful life of HVAD system components.
Patients using the HVAD ventricular assist device and their caregivers should refer to updated materials from Heartware, Inc. when they are available. Patients should contact their healthcare provider with questions about their device or if they experience any issues.
The recalled product
- Product
- 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
- Manufacturer
- Heartware, Inc.
- Category
- Medical Device — Cardiac Support
- Hazard
- controller-fault-alarm
- component-lifespan
- instruction-clarity
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)
- Serial numbers: HW24101
- HW24102
- HW24103
- HW24104
- HW24763
- HW24755FSCA
Distribution
Distribution scope not specified by the agency.
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