The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1337-2021·Announced 2021-04-14

Medtronic HVAD Controller Power Cables Recalled for Port Damage Risk

Heartware, Inc. is recalling Medtronic HVAD Controller power and data cables due to a risk of damaging controller ports from cable 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 specific Medtronic HVAD Controller power supplies, including AC and DC adapters, as well as battery, alarm, and monitor data cables. The recall affects 17,992 units, with 8,054 units distributed in the United States and the remainder distributed worldwide.

The recall is being conducted 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 ports due to wear resulting from misalignment between the cables and the ports.

Consumers who have these specific Medtronic HVAD Controller cables should contact Heartware, Inc. for instructions on how to proceed with the recall.

The recalled product

Product
Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US 2. Medtronic HVAD Controller DC Adapter, Product Number…
Manufacturer
Heartware, Inc.
Category
Medical Device — Power Supply / Cables
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.

See all 6 products in this recall →

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