Thoratec Corp.: HeartMate 3 LVAS Implant Kits Recalled for Potential Seal Interface Leaks

Agency Publication Date: May 1, 2024

Summary

Thoratec Corp. is recalling approximately 1,541 HeartMate 3 Left Ventricle Assist System (LVAS) Implant Kits because there is a potential for a leak to form at the seal between the pump's inflow tube and the titanium heart cuff. This recall affects models REF:106524US and REF:106524INT, which are critical life-support devices used to help the heart pump blood. The issue involves a specific defect in how the device seals during surgery, which can lead to serious blood loss or other complications during the implantation procedure.

Risk

A leak at the seal interface can cause blood to escape the circulatory system or allow air to enter the heart, which poses a severe risk of embolism, stroke, or death. While these devices are only used in a hospital surgical setting, a failure during or after implantation requires immediate medical intervention.

What You Should Do

Identify if your device is affected by checking the model reference numbers (REF:106524US or REF:106524INT) and the specific serial numbers starting with 'MLP-' listed in the recall documentation.
If you are a patient with a HeartMate 3 system, contact your cardiology team or healthcare provider immediately to discuss this notice and any necessary follow-up monitoring.
Healthcare facilities should immediately examine their inventory for the specific kit serial numbers listed, such as MLP-026628 through MLP-044222, and quarantine any unused units.
Medical professionals should follow the specific surgical instructions provided by Thoratec Corp. regarding the verification of the seal interface during implantation.
Contact Thoratec Corp. at their Pleasanton, California headquarters or through your authorized representative for instructions on returning affected units and obtaining potential replacements.
For further questions regarding this medical device recall, contact the FDA's consumer line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Healthcare provider notification and surgical advisory

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

Affected Products

Product: Thoratec HeartMate 3, LVAS Implant Kit (REF:106524US)

Model / REF:

REF:106524US

Recall #: Z-1692-2024

UPC Codes:

00813024013297

Lot Numbers:

MLP-026628

MLP-026733

MLP-026929

MLP-027005

MLP-027322

MLP-027363

MLP-027387

MLP-027390

MLP-027596

MLP-027678

MLP-027879

MLP-028290

MLP-028518

MLP-028665

MLP-028754

MLP-028931

MLP-029026

MLP-029108

MLP-029187

MLP-029304

MLP-029368

MLP-029462

MLP-029473

MLP-029656

MLP-029682

MLP-029686

MLP-029845

MLP-030174

MLP-030180

MLP-030215

MLP-030216

MLP-030844

MLP-030945

MLP-030993

MLP-031350

MLP-044179

MLP-044218

MLP-044220

MLP-044222

Product: Thoratec HeartMate 3, LVAS Implant Kit (REF:106524INT)

Model / REF:

REF:106524INT

Recall #: Z-1693-2024

UPC Codes:

00813024011712

Lot Numbers:

MLP-026628

MLP-026733

MLP-026929

MLP-027005

MLP-027322

MLP-027363

MLP-027387

MLP-027390

MLP-027596

MLP-027678

MLP-027879

MLP-028290

MLP-028518

MLP-028665

MLP-028754

MLP-028931

MLP-029026

MLP-029108

MLP-029187

MLP-029304

MLP-029368

MLP-029462

MLP-029473

MLP-029656

MLP-029682

MLP-029686

MLP-029845

MLP-030174

MLP-030180

MLP-030215

MLP-030216

MLP-030844

MLP-030945

MLP-030993

MLP-031350

MLP-044179

MLP-044218

MLP-044220

MLP-044222

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94232

Status: Active

Manufacturer: Thoratec Corp.

Sold By: Authorized Medical Distributors; Hospitals

Manufactured In: United States

Units Affected: 2 products (882 units; 659 units)

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, Washington, Wisconsin, West Virginia

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 · 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

Risk

What You Should Do

Identify if your device is affected by checking the model reference numbers (REF:106524US or REF:106524INT) and the specific serial numbers starting with 'MLP-' listed in the recall documentation.

If you are a patient with a HeartMate 3 system, contact your cardiology team or healthcare provider immediately to discuss this notice and any necessary follow-up monitoring.

Healthcare facilities should immediately examine their inventory for the specific kit serial numbers listed, such as MLP-026628 through MLP-044222, and quarantine any unused units.

Medical professionals should follow the specific surgical instructions provided by Thoratec Corp. regarding the verification of the seal interface during implantation.

Contact Thoratec Corp. at their Pleasanton, California headquarters or through your authorized representative for instructions on returning affected units and obtaining potential replacements.

For further questions regarding this medical device recall, contact the FDA's consumer line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: Thoratec HeartMate 3, LVAS Implant Kit (REF:106524US)

Model / REF:

REF:106524US

Recall #: Z-1692-2024

UPC Codes:

00813024013297

Lot Numbers:

MLP-026628

MLP-026733

MLP-026929

MLP-027005

MLP-027322

MLP-027363

MLP-027387

MLP-027390

MLP-027596

MLP-027678

MLP-027879

MLP-028290

MLP-028518

MLP-028665

MLP-028754

MLP-028931

MLP-029026

MLP-029108

MLP-029187

MLP-029304

MLP-029368

MLP-029462

MLP-029473

MLP-029656

MLP-029682

MLP-029686

MLP-029845

MLP-030174

MLP-030180

MLP-030215

MLP-030216

MLP-030844

MLP-030945

MLP-030993

MLP-031350

MLP-044179

MLP-044218

MLP-044220

MLP-044222

Product: Thoratec HeartMate 3, LVAS Implant Kit (REF:106524INT)

Model / REF:

REF:106524INT

Recall #: Z-1693-2024

UPC Codes:

00813024011712

Lot Numbers:

MLP-026628

MLP-026733

MLP-026929

MLP-027005

MLP-027322

MLP-027363

MLP-027387

MLP-027390

MLP-027596

MLP-027678

MLP-027879

MLP-028290

MLP-028518

MLP-028665

MLP-028754

MLP-028931

MLP-029026

MLP-029108

MLP-029187

MLP-029304

MLP-029368

MLP-029462

MLP-029473

MLP-029656

MLP-029682

MLP-029686

MLP-029845

MLP-030174

MLP-030180

MLP-030215

MLP-030216

MLP-030844

MLP-030945

MLP-030993

MLP-031350

MLP-044179

MLP-044218

MLP-044220

MLP-044222

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94232

Status: Active

Manufacturer: Thoratec Corp.

Sold By: Authorized Medical Distributors; Hospitals

Manufactured In: United States

Units Affected: 2 products (882 units; 659 units)