The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1301-2024·Announced 2024-03-27

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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…
Manufacturer
Thoratec Corp.
Category
Medical Device — Cardiac Assist System
Hazard
Affected units
22,663

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.

The notice also names 42 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Thoratec Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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