Thoratec Corp.: HeartMate II and 3 Heart Pumps Recalled for Outflow Graft Obstruction

Agency Publication Date: March 22, 2024

Summary

Thoratec Corp. (Abbott) has recalled approximately 24,903 HeartMate II and HeartMate 3 Left Ventricular Assist Systems (LVAS) due to a defect where the outflow graft can become blocked or narrowed. This condition, known as Extrinsic Outflow Graft Obstruction (EOGO), involves a buildup of material that can press on the graft, reducing its ability to move blood from the heart to the rest of the body. These critical medical implants were distributed nationwide across the U.S. and to nearly 100 countries worldwide. Because these are complex surgical implants, patients should not attempt to stop using the device and must contact their healthcare provider for medical guidance and monitoring.

Risk

Deformation of the outflow graft can lead to reduced blood flow from the pump, potentially causing the device to trigger low-flow alarms. If the obstruction becomes severe, it can result in symptoms of heart failure, serious injury, or death.

What You Should Do

Identify if your device is affected by checking your patient identification card or medical records for HeartMate II or HeartMate 3 models, specifically REF numbers 103393, 106015, 106016, 105581, or 106524.
Monitor yourself for symptoms of reduced blood flow, such as persistent shortness of breath, sudden dizziness, or unusual tiredness.
Listen for any device alarms, particularly 'Low Flow' alarms, which may indicate a developing obstruction in the outflow graft.
Contact your healthcare provider or ventricular assist device (VAD) clinical team immediately to discuss this recall and schedule any necessary diagnostic imaging to check the graft status.
Do not attempt to modify the device or change your medical routine without direct supervision from your cardiologist or VAD coordinator.
Contact Thoratec Corp. (Abbott) at their Pleasanton, California headquarters or through your local clinic if you have specific questions about the serial numbers listed in this recall notice.
For further information or to report a problem, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Healthcare provider monitoring and manufacturer consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: HeartMate II Sealed Outflow Graft with Bend Relief

Model / REF:

103393

UPC Codes:

00813024010807

Product: HeartMate II LVAS Implant Kit (US)

Model / REF:

106015

UPC Codes:

00813024011224

Product: HeartMate II LVAS Implant Kit (Outside US)

Model / REF:

106016

UPC Codes:

00813024011231

Product: HeartMate II LVAS Implant Kit (Unsealed Outflow Graft)

Model / REF:

102139

1355

103695

103693

103695-CAN

UPC Codes:

00813024010005

00813024010616

00813024010623

Product: HeartMate II LVAS Implant Kit (Sealed Graft)

Model / REF:

104911

104912

104911JPN

106515OUS

UPC Codes:

00813024011170

00813024010821

00813024011682

Product: HeartMate 3 Sealed Outflow Graft with Bend Relief (IDE/US/INT)

Model / REF:

105581

105581US

105581INT

UPC Codes:

00813024013266

00813024011675

Product: HeartMate 3 LVAS Implant Kit (IDE/US/INT)

Model / REF:

106524

106524US

106524INT

UPC Codes:

00813024013297

00813024011712

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93963

Status: Active

Manufacturer: Thoratec Corp.

Sold By: Hospitals; Surgical Centers; Specialty Cardiac Clinics

Manufactured In: United States

Units Affected: 2 products (2,240 kits; 22,663 kits)

Distributed To: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia

Agency Last Updated: April 3, 2024

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if your device is affected by checking your patient identification card or medical records for HeartMate II or HeartMate 3 models, specifically REF numbers 103393, 106015, 106016, 105581, or 106524.

Monitor yourself for symptoms of reduced blood flow, such as persistent shortness of breath, sudden dizziness, or unusual tiredness.

Listen for any device alarms, particularly 'Low Flow' alarms, which may indicate a developing obstruction in the outflow graft.

Contact your healthcare provider or ventricular assist device (VAD) clinical team immediately to discuss this recall and schedule any necessary diagnostic imaging to check the graft status.

Do not attempt to modify the device or change your medical routine without direct supervision from your cardiologist or VAD coordinator.

Contact Thoratec Corp. (Abbott) at their Pleasanton, California headquarters or through your local clinic if you have specific questions about the serial numbers listed in this recall notice.

For further information or to report a problem, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: HeartMate II Sealed Outflow Graft with Bend Relief

Model / REF:

103393

UPC Codes:

00813024010807

Product: HeartMate II LVAS Implant Kit (US)

Model / REF:

106015

UPC Codes:

00813024011224

Product: HeartMate II LVAS Implant Kit (Outside US)

Model / REF:

106016

UPC Codes:

00813024011231

Product: HeartMate II LVAS Implant Kit (Unsealed Outflow Graft)

Model / REF:

102139

1355

103695

103693

103695-CAN

UPC Codes:

00813024010005

00813024010616

00813024010623

Product: HeartMate II LVAS Implant Kit (Sealed Graft)

Model / REF:

104911

104912

104911JPN

106515OUS

UPC Codes:

00813024011170

00813024010821

00813024011682

Product: HeartMate 3 Sealed Outflow Graft with Bend Relief (IDE/US/INT)

Model / REF:

105581

105581US

105581INT

UPC Codes:

00813024013266

00813024011675

Product: HeartMate 3 LVAS Implant Kit (IDE/US/INT)

Model / REF:

106524

106524US

106524INT

UPC Codes:

00813024013297

00813024011712

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93963

Status: Active

Manufacturer: Thoratec Corp.

Sold By: Hospitals; Surgical Centers; Specialty Cardiac Clinics

Manufactured In: United States

Units Affected: 2 products (2,240 kits; 22,663 kits)

Agency Last Updated: April 3, 2024