The Recall Desk
SevereFDA (Devices)·Z-2291-2025·Announced 2025-08-20

HeartMate mobile power unit cords may disconnect from a misaligned lock

HeartMate Mobile Power Units are being recalled because misaligned V-Lock features on the power cords prevent the locking mechanism engaging properly and may cause unintended disconnect. 604 units affected.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no injury is reported in the source, so it does not escalate to Critical.

Plain-English summary

The HeartMate Mobile Power Unit, model number 107754, UDI-DI 05415067038234, part of the HeartMate 3 Left Ventricular Assist System, is being recalled. The action covers 604 units, identified by the serial numbers in the recall notice.

The stated reason is a misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect. The FDA classified the action as Class I, its most serious classification.

Distribution was worldwide, including nationwide in the United States across Alabama, Arkansas, Arizona and California among other states. The units are supplied to healthcare facilities and patients under clinical supervision.

Facilities and patients should identify affected units using the model number, UDI-DI and serial numbers above and follow the instructions issued by the manufacturer.

The recalled product

Product
Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 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 designed to provide
Manufacturer
Thoratec LLC
Category
Medical Device — Ventricular assist device accessory
Hazard
Affected units
604

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 (3)

  • Lot Code: US Model No 107754
  • UDI-DI 05415067038234 Serial 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 →

Related recalls

Same manufacturer · Thoratec LLC

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