HeartWare HVAD: Documentation Updates for Controller Fault and Component Life
Heartware is updating instructional materials for the HVAD ventricular assist device to clarify when Controller Fault alarms sound and how to troubleshoot them. Updates also address component useful life 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: FDA Class II medical device recall involving a life-sustaining cardiac implant where documentation updates clarify critical operational information (Controller Fault alarms and component lifespan). No illnesses or injuries are reported in the source, but this is a high-risk product where inadequate instructions could lead to harm.
Plain-English summary
This is a Class II recall from the FDA involving the PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT. Heartware is providing updates to the system instructions for use and patient manual to address gaps in documentation regarding device operation.
The updates address two key areas: clarifying the conditions under which the Controller Fault alarm may sound on the HVAD system and the recommended troubleshooting actions, and clarifying instructions relating to the useful life of HVAD system components. These updates are intended to improve understanding of device operation and maintenance among patients and healthcare providers.
The recall affects 125 implant kits with worldwide distribution.
The recalled product
- Product
- PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
- Manufacturer
- Heartware, Inc.
- Hazard
- controller-fault
- instruction-defect
- component-wear
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)
- GTIN 00888707005364
- Serial Numbers: HW43366
- HW42611
- HW43316
- HW43247
- HW43248
- HW42405
- HW43276
- HW43251
- HW43313
- HW43322
- HW43257
- HW43262
- HW43258
- HW43270
- HW43197
- HW43157
- HW43253
- HW42375
- HW42400
Distribution
Distribution scope not specified by the agency.
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