HeartWare HVAD Ventricular Assist Device Documentation Update
HeartWare is updating documentation for 380 HVAD cardiac assist devices to clarify Controller Fault alarm conditions and device lifetime instructions.
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 device is a Class II medical device providing life-sustaining cardiac support. The recall addresses documentation clarity on critical functions including alarm conditions and useful life. No adverse events or injuries are mentioned in the source text. This fits the rubric criterion for High (3): a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The HVAD (HeartWare Ventricular Assist Device) is a cardiac assist device designed to support heart function in patients with advanced heart failure. The device is sold in the United States and distributed worldwide.
HeartWare, Inc. is recalling certain HVAD pump units to update the Instructions for Use (IFU) and patient manual. The updated documentation will clarify (1) the conditions under which a Controller Fault alarm may sound and the recommended troubleshooting actions, and (2) instructions related to the useful life of HVAD system components.
The recall affects 380 units worldwide, each identified by specific serial numbers beginning with HW. Patients and healthcare providers with affected devices should contact HeartWare for the updated documentation once it becomes available.
The recalled product
- Product
- STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
- Manufacturer
- Heartware, Inc.
- Hazard
- inadequate-instructions
- device-malfunction
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: hw1005
- HW1015
- HW1020
- HW1021
- HW1022
- HW1023
- HW1025
- HW1028
- HW1031
- HW1033
- HW107
- HW1088
- HW1089
- HW1090
- HW1091
- HW1092
- HW1138
- HW1139
- HW1142
- HW1143
Distribution
Distribution scope not specified by the agency.
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