CLASS II Device recall · Reported 8 Jan 2020 · FDA Enforcement Report
HeartMate 3 Mobile Power Unit recalled by Thoratec
Thoratec is recalling HeartMate 3 Mobile Power Unit, distributed nationwide in the US. The recall was initiated on 2 Dec 2019 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-0746-2020
- FDA event ID
- 84379
- Recalling firm
- Thoratec, Pleasanton, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Dec 2019
- FDA classified
- 27 Dec 2019
- Reported
- 8 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 2 Dec 2019 | Recall initiated by company | |
| 27 Dec 2019 | Classified by FDA | +25 days |
| 8 Jan 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power unit that can be used to power the left ventricular assist system, which could lead to no or reduced blood flow from the left ventricular assist system.
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
HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, REF 106524US, UDI or GTIN: 00813024013297, and 106524, UDI or GTIN: 00813024011712 - Product Usage: Provides power to the System Controller and pump. - Provides power to the System Monitor when it is connected to the Power Module. - Connects the System Monitor to the System Controller for monitoring purposes. - Echoes System Controller alarms. The Mobile Power Unit is for home or clinical use when the patient does not require monitoring using the System Monitor. The Mobile Power Unit is used when the patient is indoors, stationary, or sleeping. The System Controller and the Mobile Power Unit are connected through the Mobile Power Unit patient cable. The cable transfers power from the Mobile Power Unit to the System Controller.
Where it was distributed
US Nationwide distribution in the states of MN, PA, IL, NJ, WI, AZ, AR, TN, MO, TX, MA, NE, MI, CA, NC, CO, OH, DE, FL, NY, IN, GA, VA, DC, CT, OK, UT, KY, MD, OR, NM, ME, SC, IA, WA, LA, NV, AL, KS, MS, WV.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichigan
Questions about this recall
Why was it recalled?
Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power unit that can be used to power the left ventricular assist system, which could lead to no or reduced blood flow from the left ventricular assist system.
Which lots are affected?
All serial numbers.
Where was it sold?
US Nationwide distribution in the states of MN, PA, IL, NJ, WI, AZ, AR, TN, MO, TX, MA, NE, MI, CA, NC, CO, OH, DE, FL, NY, IN, GA, VA, DC, CT, OK, UT, KY, MD, OR, NM, ME, SC, IA, WA, LA, NV, AL, KS, MS, WV.
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.
More recalls from Thoratec
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | HeartMate HM 11V Li-ion Backup Battery, ABT recalled by Thoratec | Thoratec | Device Malfunction | Nationwide |
| 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 |
Other Patient Monitors recalls
All 1,014| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | nGenuity Patient Monitor with Capnography recalled | Criticare Technologies | Device Malfunction | Nationwide |
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |