The Recall Desk
HighFDA (Devices)·Z-1570-2025·Announced 2025-04-23

[pending] HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Re

Pending LLM rewrite. Source: FDA_DEVICE Z-1570-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow Wrench or No External Power alarms. If MPU losses power, System Controller can support the pump up to 15 minutes, and if not switched to rechargeable batteries, pump may lose power.

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 — Devices

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.

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