FDA Recalls HeartMate II Left Ventricular Assist Systems for Graft Obstruction
Thoratec Corp. recalls HeartMate II left ventricular assist system kits due to outflow graft deformation that could obstruct blood flow. The FDA has classified this as a Class I recall affecting 2,240 units distributed worldwide.
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: This is an FDA Class I recall, the agency's highest classification indicating a potential hazard that could result in serious adverse health consequences. The hazard—outflow graft deformation in a critical cardiac support device—poses direct risk to proper blood circulation. No illnesses or deaths are reported in the source documentation.
Plain-English summary
Thoratec Corp. is recalling multiple configurations of the HeartMate II Left Ventricular Assist System (LVAS) and related implant kits. The recall affects 2,240 units that were distributed worldwide, including throughout the United States and to numerous countries.
The recalled devices pose a risk of Extrinsic Outflow Graft Obstruction (EOGO), where the outflow graft component can become deformed. This deformation could reduce or obstruct blood flow through the graft, potentially compromising the device's ability to assist circulation from the left ventricle to the aorta.
The affected devices include multiple kit configurations with different reference numbers and serial numbers spanning a wide range. Healthcare providers and facilities should check their inventory against the provided serial number lists to identify any affected units in their care.
Patients who have received these devices and healthcare providers managing patients with HeartMate II systems should contact Thoratec Corp. for further information and guidance regarding the recalled units.
The recalled product
- Product
- HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate II LVAS Implant Kit, OUS REF 106016 Update (February 14, 2024) HeartMate II Left Ventricular As
- Manufacturer
- Thoratec Corp.
- Hazard
- graft-deformation
- outflow-obstruction
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 (5)
- 2024) HeartMate II LVAS: 1. 102139 (OUS)
- includes Unsealed Outflow Graft with Bend Relief 2. 1355 (US)
- includes Unsealed Outflow Graft with Bend Relief 3. 103695 (US)
- includes Unsealed Outflow Graft with Bend Relief 4. 103693 (OUS)
- does not include Outflow Graft 8. 103695-CAN
Distribution
Distributed nationwide across the United States.
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