HeartWare HVAD System: Updated Cleaning Instructions for Power Connectors
Updated cleaning instructions are being provided for the HeartWare HVAD System's power connectors. Improper cleaning can remove protective lubricant required for proper power switching.
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 Class II recall provides updated cleaning instructions to prevent improper maintenance that could affect power switching. No illnesses, injuries, or deaths are reported in the source, making this a precautionary instructional update.
Plain-English summary
The HeartWare Ventricular Assist Device (HVAD) System is a mechanical cardiac pump used to support heart function in patients with advanced heart failure. Heartware, Inc. is providing updated cleaning instructions for the Controller AC Adapter, DC Adapter, and Battery connectors.
The update clarifies that the power source connector pins should not be cleaned, as doing so can remove a protective lubricant applied to the pins. This lubricant is essential for proper power switching functionality.
The recall affects approximately 197,889 units distributed throughout the United States and more than 50 countries worldwide. Patients and healthcare providers who use or service these devices should review and follow the updated cleaning instructions provided by Heartware, Inc. to ensure proper device operation and maintenance.
The recalled product
- Product
- HeartWare Ventricular Assist Device (HVAD) System
- Manufacturer
- Heartware, Inc.
- Affected units
- 197,889
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)
- All lots/serials for the following product model numbers: 1440
- 1400
- 1401
- 1401AU
- 1401BR
- 1401CA
- 1401CH
- 1401DE
- 1401GB
- 1401IL
- 1401IN
- 1401IT
- 1401JP
- 1401US
- 1403US
- 1407AR
- 1407AU
- 1407BR
- 1407CA
- 1407CA-CLIN
Distribution
Distribution scope not specified by the agency.
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