The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-2290-2025·Announced 2025-08-20

HeartMate mobile power unit cords recalled over locking feature that may disconnect

Abbott is recalling 53 HeartMate Mobile Power Unit AC power cords, model 107760, because a misaligned V-Lock may not engage and can allow an unintended disconnect. The FDA classified this as Class I.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The rubric assigns 5 to any FDA Class I recall, and the FDA classified this power cord action as Class I.

Plain-English summary

The HeartMate Mobile Power Unit AC Power Cord, model and catalog number 107760, UDI-DI 05415067038258, is being recalled. The recall covers 53 units distributed across the United States and in Canada and Japan; affected lot numbers are listed in an attachment to the recall notice. The cord is part of the HeartMate 3 Left Ventricular Assist System, equipment used to provide circulatory support to people with advanced heart failure.

The recall was issued because a misaligned V-Lock feature on the Mobile Power Unit power cords prevents the locking mechanism from properly engaging with the Mobile Power Unit, which may cause an unintended disconnect. The FDA classified the action as Class I, its most serious category.

Patients and clinicians using a HeartMate system should follow the manufacturer's instructions for identifying affected cords and obtaining a replacement, and should not stop using the system without clinical advice. Questions should go to the patient's implanting centre.

The recalled product

Product
Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device…
Manufacturer
Thoratec LLC
Category
Medical Device — Cardiac Support System
Hazard
Affected units
53

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 (4)

  • Lot Code: US Model No 107760
  • UDI-DI 05415067038258
  • For Lot Numbers
  • see Attachment F.

Distribution

Distributed nationwide across the United States.

The notice also names 38 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Thoratec LLC 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 2 products in this recall →

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