The Recall Desk
HighFDA (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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a defect poses a risk of harm (damage to controller ports) but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

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: 14
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 →

Related recalls

Same manufacturer · Heartware, Inc.

See all →