The Recall Desk
SevereFDA (Devices)·Z-2290-2025·Announced 2025-08-20

HeartMate Mobile Power Unit AC Power Cord misalignment recall

Thoratec is recalling HeartMate 3 Mobile Power Unit AC Power Cords (Model 107760) with a misaligned V-Lock feature that may prevent proper engagement and cause unintended power disconnection.

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 classified this as a Class I recall. Although no injuries or deaths have been reported, a power cord disconnection on a life-critical ventricular assist device presents serious risk of harm per FDA Class I standards.

Plain-English summary

Thoratec LLC is recalling the HeartMate 3 Left Ventricular Assist System Mobile Power Unit AC Power Cord (Model 107760). The device has been distributed worldwide, including throughout the United States, Canada, and Japan.

The AC power cord has a V-Lock feature that is misaligned, preventing the locking mechanism from properly engaging with the Mobile Power Unit. This may cause the power cord to disconnect unintentionally, interrupting power to the life-critical heart pump device.

A total of 53 affected units have been identified. Specific lot information is available in the FDA recall documentation.

Patients with HeartMate 3 systems should contact Thoratec or their healthcare provider immediately to verify whether their device is affected and to obtain a replacement power cord if needed. The affected device should not be used until the power cord has been replaced.

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 desi
Manufacturer
Thoratec LLC
Category
Medical Device — Cardiac Assist Device
Hazard
  • connector-misalignment
  • power-disconnection-risk

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.

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