Medtronic HVAD Alarm Adapter Recalled for Potential Port Damage
Heartware, Inc. is recalling 418 Medtronic HVAD Alarm Adapters because cable misalignment may cause damage to the HVAD Controller ports.
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 agency classification is Class I, which is typically a low-risk recall. The hazard is potential physical damage to the device ports due to wear, with no reported injuries or illnesses in the source text.
Plain-English summary
Heartware, Inc. is recalling 418 units of the Medtronic HVAD Alarm Adapter, Product Number 1450. The recall covers units distributed worldwide, with 315 units in the United States. All lot codes are affected.
The recall is due to the potential for the HVAD Alarm Adapter, along with other specific cables, to cause damage to the HVAD Controller ports. This damage may occur when inserting the cables into the ports due to wear from misalignment of the cables to the port.
The source text does not specify instructions for consumers or patients on how to proceed with this recall.
The recalled product
- Product
- Medtronic HVAD Alarm Adapter, Product Number: 1450
- 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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