Medtronic HVAD Monitor Data Cable Recalled for Potential Port Damage
Heartware, Inc. is recalling Medtronic HVAD Monitor Data Cables because they may damage HVAD Controller ports due to wear from misalignment.
What this means for you
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: The recall is classified as FDA Class I, which typically indicates a low probability of adverse health consequences. The hazard is potential equipment damage due to wear, with no reported injuries or illnesses in the source text.
Plain-English summary
Heartware, Inc. is recalling Medtronic HVAD Monitor Data Cables, Product Number 1575. The recall involves 1,337 units, with 1,110 units distributed in the United States and the remainder distributed worldwide. All lot codes are affected.
The recall is being issued because there is a potential for the cables to cause damage to the HVAD Controller ports. This damage may occur when inserting the cables into the Controller ports due to wear from misalignment of the cables to the port. The source text notes that similar risks exist for Controller power cables (AC Adapter, DC Adapter, and Battery cables) and the HVAD Alarm Adapter.
The source text does not specify specific instructions for consumers or patients regarding immediate actions to take, such as stopping use or contacting a provider. It does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- Medtronic HVAD Monitor Data Cable, Product Number: 1575
- Manufacturer
- Heartware, Inc.
- Category
- Medical Device — Cardiovascular
- Hazard
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 (1)
- All lot codes
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 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.
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