HeartWare HVAD Implant Kit Instructional Update for Fault Alarms
The FDA is issuing updated instructions for the HeartWare HVAD ventricular assist device to clarify when controller fault alarms sound and when device components should be replaced. No patient harm has been reported.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The recall addresses instructional clarity regarding alarm conditions and component useful life, rather than a product defect. Per the rubric, informational and instructional updates without reported harm are classified as Moderate.
Plain-English summary
The PUMP 1104 HVAD (HeartWare Ventricular Assist Device) Implant Kit, Model Number 1104, is the subject of an FDA Class II recall. Approximately 10,287 units have been distributed worldwide to hospitals and healthcare facilities.
The FDA and manufacturer are providing updated instructions for use (IFU) and patient manual (PM) to clarify two areas: (1) the specific conditions under which a Controller Fault alarm may sound and the recommended troubleshooting actions to take when it does, and (2) instructions relating to the useful life of HVAD system components, including when replacement or maintenance is needed.
Patients with implanted HVAD devices and their healthcare providers should review the updated instructions when made available by Heartware, Inc. Anyone with questions about their device or the updated instructions should contact their healthcare provider or the manufacturer directly for additional information and guidance.
The recalled product
- Product
- PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
- Manufacturer
- Heartware, Inc.
- Affected units
- 10,287
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 none
- Serial Numbers: HW10001
- HW10002
- HW10003
- HW10004
- HW10005
- HW10006
- HW10007
- HW10008
- HW10009
- HW10010
- HW10011
- HW10012
- HW10013
- HW10014
- HW10015
- HW10016
- HW10017
- HW10018
- HW10019
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
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