Abbott/Thoratec Corp. Recalls HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due to Long-term Buildup Causing an Obstruction
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Product Names: HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS)
- Product Codes: DSQ
- Model Numbers: Full List of Affected Devices
- Distribution Dates: Starting in April 21, 2008
- Devices Recalled in the U.S.: 13,883
- Date Initiated by Firm: February 19, 2024
Device Use
The HeartMate II and HeartMate 3 Left Ventricular Assist Systems (LVAS) are used to help the heart pump blood when it's not able to do so effectively on its own.
The HeartMate II and 3 are used for both short- and long-term support in adult patients with severe left ventricular heart failure. It can be used while waiting for a heart transplant, to help the heart recover, or as a permanent solution when a transplant isn't an option. HeartMate 3 can also be used in pediatric patients.
Both devices work by taking over the pumping function of the left ventricle, the main pumping chamber of the heart. They divert blood from the weakened left ventricle and propel it into the body's main artery, the aorta, helping to circulate blood throughout the body. The devices are used both inside and outside of the hospital.
Reason for Recall
Abbott/Thoratec Corp. is recalling HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due to an issue called Extrinsic Outflow Graft Obstruction, (EOGO). This happens when biological material builds up between the HeartMate Outflow Graft and the Outflow Graft Bend relief or additional components added during surgery. This buildup can obstruct the device, making it less effective in helping the heart pump blood. It can trigger alarms indicating low blood flow and affect the device's ability to help the heart properly. The accumulation of biological material typically occurs over two years or more.
The use of affected LVAS may cause serious adverse health consequences and in worst cases, could result in death.
There have been 273 reported injuries and 14 reports of death associated with this issue.
Who May be Affected
- Healthcare Professionals using the HeartMate II and HeartMate 3 Left Ventricular Assist Systems (LVAS) to provide care.
- People receiving care through either the HeartMate II or HeartMate 3 Left Ventricular Assist Systems (LVAS)
What to Do
On February 19, 2024, Thoratec Corporation sent all affected customers an Urgent Medical Device Correction Letter.
The letter requested customers to:
- Complete and return acknowledgment form included with this letter.
- Abbott will continue to send letters to new consignees until the corrective measures are in place.
- Pay attention to low flow alarms as this is the first symptom of significant outflow obstruction. Additional guidance was provided on how to diagnose unresolved low flow associated with outflow graft obstruction.
Contact Information
Customers in the U.S. with questions about this recall should contact Abbott/Thoratec Corporation at 1-800-456-1477.
Full List of Affected Devices
Unique Device Identifier (UDI)/Model Numbers of US marketed devices (see links above for all affected devices including OUS marketed devices and devices used in investigational studies):
| Device | UDI-ID | Firm Reference Number |
|---|---|---|
| HeartMate II Sealed Outflow Graft with Bend Relief | 00813024010807 | 103393 |
| HeartMate II LVAS Implant Kit | 00813024011224 | 106015 |
| HeartMate II LVAS Implant Kit (Unsealed Outflow Graft with Bend Relief) | 00813024010005 | 1355 |
| HeartMate II LVAS Implant Kit (with RSOC Controller) | 00813024010616 | 103695 |
| HeartMate II LVAS Implant Kit (with Sealed Graft) | 00813024011170 | 104911 |
| HeartMate II LVAS Implant Kit (Used for pump exchange, No Graft) | 00813024011996 | 107801 |
| HeartMate 3 Sealed Outflow Graft with Bend Relief | 00813024013266 | 105581US |
| HeartMate 3 LVAS Implant Kit | 00813024013297 | 106524US |
Additional Resources:
- Class 1 Device Recall HeartMate II Left Ventricular Assist System (fda.gov)
- Class 1 Device Recall HeartMate 3 Left Ventricular Assist System (fda.gov)
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.