HVAD Ventricular Assist Device Instructions Updated for Alarm Clarification
Heartware, Inc. is updating instructions for the HVAD ventricular assist device to clarify Controller Fault alarm conditions and component useful life. The recall affects 45 units distributed worldwide.
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 a Class II recall involving documentation and instruction updates with no reported illnesses, injuries, or hospitalizations. The recall is preventive in nature, clarifying existing instructions rather than addressing reported device failures.
Plain-English summary
The HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100, is subject to a Class II recall affecting 45 units distributed worldwide. The recalled units are identified by specific serial numbers ranging from HW001 to HW181.
Heartware, Inc. is providing updates to the Instructions for Use (IFU) and patient manual to clarify two key points: the conditions under which the device's Controller Fault alarm may sound, and instructions regarding the useful life of HVAD system components. These documentation updates will help users and healthcare providers better understand device operation and maintenance requirements.
Patients and healthcare providers who have received or implanted the HVAD device should contact Heartware for the updated documentation. No specific harm or adverse events are reported in connection with this recall.
The recalled product
- Product
- HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
- Manufacturer
- Heartware, Inc.
- Hazard
- Affected units
- 45
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: HW001
- HW012
- HW016
- HW017
- HW023
- HW025
- HW028
- HW044
- HW045
- HW046
- HW047
- HW049
- HW050
- HW051
- HW061
- HW064
- HW083
- HW084
- HW086
- HW091
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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