The Recall Desk
ModerateFDA (Devices)·Z-1341-2021·Announced 2021-04-14

Medtronic HVAD Monitor Recall Due to Cable Port Damage Risk

Heartware is recalling Medtronic HVAD Packaged Monitors because worn cables may damage controller ports during insertion.

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. However, the specific hazard described is physical damage to equipment ports due to wear, rather than a direct biological or electrical hazard to the patient, and no injuries or illnesses are reported in the source text.

Plain-English summary

Heartware, Inc. is recalling Medtronic HVAD Packaged Monitors, including various model numbers such as 1500, 1511, and 1521. The recall involves 3,283 devices, with 1,824 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 ports due to wear from misalignment of the cables to the port.

The source text does not specify specific actions for consumers or patients. Users of these devices should contact Heartware, Inc. or their healthcare provider for further instructions on how to proceed with the recall.

The recalled product

Product
Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 1511IL, 1511IN, 1511IT, 1511JP, 1511MY, 1520CLIN-AU, 1520CLIN-DE, 1520CLIN-GB, 1520JP, 1520US, 1521AU, 1521BR, 1521CA, 1521CH, 1521DE, 1521GB, 15
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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Same hazard · equipment damage

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