CLASS II ONGOING Device recall · Reported 24 Jun 2026 · FDA Enforcement Report
HeartMate HM 11V Li-ion Backup Battery, ABT recalled by Thoratec
Thoratec is recalling HeartMate HM 11V Li-ion Backup Battery, ABT, distributed nationwide in the US. The recall was initiated on 13 May 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2520-2026
- FDA event ID
- 99023
- Recalling firm
- Thoratec, Pleasanton, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 May 2026
- FDA classified
- 18 Jun 2026
- Reported
- 24 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 13 May 2026 | Recall initiated by company | |
| 18 Jun 2026 | Classified by FDA | +36 days |
| 24 Jun 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to 11 volt Backup Battery failures.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The HeartMate 11 Volt Lithium Ion Standalone Backup Battery is a component of the HeartMate 3" System Controller and provides power to the System Controller. The HeartMate System Controller is an external device that manages the HeartMate Left Ventricular Assist System (LVAS), including alarms, system monitoring, and communication. It contains an internal 11V lithium-ion backup battery that provides at least 15 minutes of emergency power should the main system power source fail. The backup battery must be properly installed, charges automatically during normal use, and has a 36-month service life from date of manufacture. Component: Yes, HeartMate 3" System Controller
Where it was distributed
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Canada, Germany, Japan, Netherlands, Poland, Spain.
Nationwide AlabamaArkansasArizonaCaliforniaDistrict of ColumbiaDelawareFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesotaMissouri
Questions about this recall
Why was it recalled?
Due to 11 volt Backup Battery failures.
Which lots are affected?
Lot Code: Model Number: 106128 UDI/GTIN 05415067039880 Serial Numbers Distributed in US: See Attachment E for serial numbers distributed.
Where was it sold?
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Canada, Germany, Japan, Netherlands, Poland, Spain.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 99023This product is part of a recall event; the main page for the event is HeartMate 3" System Controller recalled by Thoratec.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | HeartMate 3" System Controller recalled by Thoratec | Thoratec | Device Malfunction | Nationwide | |
| CLASS II | HeartMate 3 Left Ventricular System (LVAS) Kits recalled by Thoratec | Thoratec | Device Malfunction | Nationwide |
More recalls from Thoratec
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | HeartMate 3 Left Ventricular System (LVAS) Kits recalled by Thoratec | Thoratec | Device Malfunction | Nationwide |
| Device | CLASS II | HeartMate 3" System Controller recalled by Thoratec | Thoratec | Device Malfunction | Nationwide |
| Device | CLASS II | CentriMag Blood Pump recalled by Thoratec | Thoratec | Particulate Matter | Nationwide |
| Device | CLASS II | HeartMate 3 Left Ventricular System (LVAS) Kits recalled by Thoratec | Thoratec | Device Malfunction | Nationwide |
| Device | CLASS II | HeartMate II¿ LVAS Implant Kit recalled by Thoratec | Thoratec | Device Malfunction | Nationwide |
Other Patient Monitors recalls
All 1,022| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Passport Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | T1 Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | cPM Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneVision Series Telemetry Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | Panorama and Telemetry Monitoring System recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |