The Recall Desk
Agency classClass IOur severity:SevereFDA (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.

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 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…
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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