HeartMate 3 Left Ventricular Assist System recalled for outflow graft obstruction
The FDA is recalling the HeartMate 3 Left Ventricular Assist System due to observed outflow graft deformation that can obstruct blood flow. Patients with implanted devices should contact their healthcare provider.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification establishes a minimum Severe rating. The hazard—graft deformation in a life-critical cardiac assist device—poses significant risk, but no illnesses, injuries, or deaths are reported in the source, preventing a Critical designation.
Plain-English summary
The FDA is issuing a Class I recall for the HeartMate 3 Left Ventricular Assist System (LVAS), manufactured by Thoratec Corp. The recall affects multiple configurations: the HeartMate 3 Sealed Outflow Graft with Bend Relief and the HeartMate 3 LVAS Implant Kit, which are used to treat patients with advanced heart failure.
The hazard involves extrinsic outflow graft obstruction (EOGO), characterized by deformation of the outflow graft. This deformation can obstruct blood flow through the device, which is critical for patients who depend on the system for cardiac function.
Approximately 22,663 kits have been distributed worldwide, including throughout the United States and to numerous countries outside the U.S. Affected devices are identified by specific model numbers and serial numbers provided by the manufacturer.
Patients who have received an implant should contact their healthcare provider to discuss their device and determine whether any monitoring or evaluation is needed. Healthcare providers should review the FDA recall notice for complete information on affected serial numbers and model numbers.
The recalled product
- Product
- HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LV
- Manufacturer
- Thoratec Corp.
- Hazard
- extrinsic-outflow-graft-obstruction
- graft-deformation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- HeartMate 3 LVAS Model Numbers: 1. 105581 (IDE
Distribution
Distributed nationwide across the United States.
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