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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 125
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.
Part of a larger recall action
This product is one of 9 recalled by Heartware, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
Same manufacturer · Heartware, Inc.
See all →- HighHVAD Ventricular Assist Device Instructions Updated for Controller Alarm and Lifespan
FDA (Devices) · 2023-12-13
- ModerateHeartWare HVAD Implant Kit Instructional Update for Fault Alarms
FDA (Devices) · 2023-12-13
- HighMedical Device Instruction Update: HVAD Ventricular Assist Device Clarifications
FDA (Devices) · 2023-12-13
- HighHVAD Ventricular Assist Pump Model 1104CA: Instructions for Fault Alarm and Lifespan
FDA (Devices) · 2023-12-13
- HighHVAD Ventricular Assist Device Updated Instructions for Alarm Conditions
FDA (Devices) · 2023-12-13
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- CriticalHeartware HVAD Pump Accessories Recalled Over Increased Mortality and Device Failures
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- SevereHeartWare HVAD Recall Issued for Internal Controller Alarm Battery Failures
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