Severe FDA (Devices)·Z-1570-2025·Announced 2025-04-23

HeartMate Mobile Power Unit electrical malfunction may cause loss of power

Thoratec LLC is recalling HeartMate Mobile Power Units due to an electrical component defect that may prevent the unit from turning on, cause unprompted shut down, or trigger false alarms. If power is lost and not switched to rechargeable batteries within 15 minutes, the connected pump may lose power.

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: The FDA classified this as Class I, which by rubric definition requires a minimum score of 4. This is a critical life-support medical device where electrical malfunction can lead to loss of power to an implanted Left Ventricular Assist System, creating risk of serious patient harm.

Plain-English summary

Thoratec LLC is recalling 1,661 HeartMate Mobile Power Units (MPUs) used with HeartMate 3 and HeartMate II Left Ventricular Assist Systems. The recalled units were distributed worldwide between April 2024 and February 2025 across the United States and multiple countries. The units are identified by UDI-DI 05415067038234 and specific serial numbers detailed in the notice.

The MPU contains an electrical component that may malfunction and prevent the unit from turning on, cause unprompted shut downs, or trigger unexpected restarts. When this occurs, the System Controller may display Yellow Wrench or "No External Power" alarms.

If the MPU loses power and the System Controller is not switched to rechargeable batteries, the pump can only operate for up to 15 minutes before losing power. This creates a potential risk to patients dependent on the HeartMate system for continued cardiac support.

Patients and healthcare providers with affected units should contact Thoratec LLC for guidance. The recalled product includes reference numbers 107754 (North America), 107758 (Europe), 107758AU (Australia), 107758UK (United Kingdom), and L107758 (European rental).

The recalled product

Product: HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System.
Manufacturer: Thoratec LLC
Category: Medical Device — Left Ventricular Assist System / Power Unit
Hazard: electrical-malfunction
loss-of-power
device-failure
Affected units: 1,661

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 (20)

20226264
20226265
20226266
20226267
20226268
20226269
20226270
20226271
20226272
20226273
20226274
20226275
20226276
20226277
20226278
20226279
20226280
20226281
20226282
20226283

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Same manufacturer · Thoratec LLC

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