The Recall Desk
ModerateFDA (Devices)·Z-1340-2021·Announced 2021-04-14

Medtronic HVAD Battery Recall for Potential Controller Port Damage

Heartware, Inc. is recalling Medtronic HVAD Batteries because controller 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 typically indicates a low probability of adverse health consequences. The hazard is limited to 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 Medtronic HVAD Batteries, including product numbers 1650, 1650CA-CLIN, and 1650DE. The recall involves 114,133 devices, with 66,613 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 instructions for consumers or patients on how to proceed, nor does it report any specific injuries or illnesses associated with this defect.

The recalled product

Product
Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
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 →

Related recalls

Same manufacturer · Heartware, Inc.

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Same hazard · device damage

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