The Recall Desk
ModerateFDA (Devices)·Z-1336-2021·Announced 2021-04-14

Medtronic HVAD Controller Recall for Potential Port Damage

Heartware is recalling Medtronic HVAD Controllers because power and data cables may damage 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 is typically associated with a reasonable probability of serious adverse health consequences or death. However, the specific hazard described is physical damage to the device ports due to wear, and the source text does not report any illnesses, injuries, or deaths. Per the rubric, when the source explicitly states no illnesses/injuries are reported and the hazard is theoretical or mechanical without reported harm, the score is capped at 3. Given the lack of reported harm and the nature of the defect (port damage rather than immediate physiological failure), a score of 2 (Moderate) is appropriate as it represents a precautionary recall for a potential defect without confirmed adverse health outcomes.

Plain-English summary

Heartware, Inc. is recalling the Medtronic HVAD Controller, including product numbers 1400, 1401, 1403, and 1407 series. The recall involves 56,018 units, with 28,449 distributed in the United States and the remainder distributed worldwide.

The recall is issued because there is a 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. 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 does not specify specific consumer actions or report any illnesses or injuries associated with this recall.

The recalled product

Product
Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR
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.

See all 6 products in this recall →

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