Reported Apr 23, 2025 · Ongoing

HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with…

Thoratec LLC

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Thoratec LLC · 6035 Stoneridge Dr · Pleasanton, CA · 94588-3270

Is this the product you have?

  • HeartMate Mobile Power UnitREF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System
Lot codes and dates
  • UDI-DI05415067038234. MPUs distributed between April 2024 and February 2025
  • Serial Numbers

    1,661 of 1,661 codes

    • 20226263
    • 20226264
    • 20226265
    • 20226266
    • 20226267
    • 20226268
    • 20226269
    • 20226270
    • 20226271
    • 20226272
    • 20226273
    • 20226274
    • 20226275
    • 20226276
    • 20226277
    • 20226278
    • 20226279
    • 20226280
    • 20226281
    • 20226282
    • 20226283
    • 20226284
    • 20226285
    • 20226286
    • 20226287
    • 20226288
    • 20226289
    • 20226290
    • 20226291
    • 20226292
    • 20240622
    • 20240623
    • 20240624
    • 20240625
    • 20240626
    • 20240627
    • 20240628
    • 20240629
    • 20240630
    • 20240631
    • 20240632
    • 20240633
    • 20240634
    • 20240635
    • 20240636
    • 20240637
    • 20240638
    • 20240639
    • 20240640
    • 20240641
    • 20240642
    • 20240643
    • 20240644
    • 20240645
    • 20240646
    • 20240647
    • 20240648
    • 20240649
    • 20240650
    • 20240651
Amount recalled
1661

Where it was sold

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:16 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.