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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the…"
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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