Skip to main content
Recall Canary
← Back to all recalls
MEDICAL DEVICE RECALLMODERATE

HeartMate 3 LVAS Backup Battery

Thoratec recalls HeartMate 3 LVAS kits (model 106524US) due to 11V backup battery failures.

What to do

If you have a HeartMate 3 LVAS kit, contact Thoratec LLC or your healthcare provider immediately to determine if your device is affected and to receive instructions for battery replacement or other corrective actions. Do not ignore any alarms or warnings from the system.

Recalled
Listed
Updated
Recall No.
Z-2520-2026
Agency
FDA
Firm
Thoratec LLC
Recall ID
99023
Status
ONGOING

Why it was recalled

Thoratec LLC is recalling the HeartMate 3 Left Ventricular Assist System (LVAS) Kits, model 106524US, due to failures of the 11-volt backup battery. The backup battery is a component of the system's external controller, and its failure can lead to loss of pump support, posing a serious health risk to patients.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductLot codeRecall #UDI-DIModel/Catalog number
HeartMate 3" System Controller–Z-2519-202605415067039446106531US
HeartMate 3 Left Ventricular System (LVAS) Kits–Z-2518-202605415067039323106524US
HeartMate HM 11V Li-ion Backup Battery, ABT–Z-2520-202605415067039880106128
HeartMate 3" System Controller106531US–05415067039446106531US
HeartMate HM 11V Li-ion Backup Battery, ABT106128–05415067039880106128
HeartMate 3 Left Ventricular System (LVAS) Kits106524US–05415067039323106524US

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Device Defect recalls

← Back to all recalls

Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification