Thoratec Corp.: Heartmate LVAS Implant Kits and Coring Knives Recalled for Dullness

Agency Publication Date: September 29, 2023

Summary

Thoratec Corp. is recalling 2,681 Heartmate 3 LVAS Implant Kits and Heartmate XVE & Heartmate II Apical Coring Knives due to reports of knives that are not sharp enough to complete surgery. If the knife is dull, it may be unable to start or finish the coring procedure, requiring the medical team to find a backup knife during an active operation. This defect can lead to extended surgical times and increased risks for patients undergoing heart assist device implantation. Consumers should contact their healthcare provider or the manufacturer for further instructions.

Risk

Inadequate sharpness of the apical coring knife can prevent the surgeon from completing the necessary incisions during heart surgery. This causes delays while a replacement knife is sourced, potentially extending the time the patient is under anesthesia or on life support.

What You Should Do

Identify if your device is affected by checking the product packaging for the following Reference (REF) numbers: 106524US, 106524INT, or 1050.
For Heartmate 3 LVAS Implant Kit (REF 106524US), check for serial numbers in these ranges: MLP-034137 to MLP-034744, MLP-035485 to MLP-035714, MLP-036330 to MLP-037708, MLP-038104 to MLP-038999, MLP-039000 to MLP-039999, MLP-040000 to MLP-040999, and MLP-041000 to MLP-041621.
For Heartmate 3 LVAS Implant Kit (REF 106524INT), check for serial numbers: MLP-032482, MLP-035542 to MLP-035667, MLP-037218 to MLP-037527, MLP-038008 to MLP-038989, MLP-039014 to MLP-039945, MLP-040009 to MLP-040896, and MLP-041013 to MLP-041589.
For standalone Apical Coring Knives (REF 1050), check for serial numbers in the range 132849 to 135062, including specific numbers: 135021-135025, 134241-134246, 134248, 134250, 134251, 134240, 135060, 135061, 135062, 134247, 132849-132853, and 134239.
If you are a healthcare provider, ensure a backup coring knife is available and inspected for sharpness before beginning any implantation procedure.
Contact Thoratec Corp. at their Pleasanton, California location or your local representative for more information regarding the voluntary notification letter sent on August 7, 2023.
Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls if you have additional questions or need to report a problem.

Your Remedy Options

Other Action

Manufacturer notification and guidance

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

Affected Products

Product: Heartmate 3 LVAS Implant Kit

Model / REF:

REF: 106524US

REF: 106524INT

Lot Numbers:

MLP-034137 to MLP-034744

MLP-035485 to MLP-035714

MLP-036330 to MLP-037708

MLP-038104 to MLP-038999

MLP-039000 to MLP-039999

MLP-040000 to MLP-040999

MLP-041000 to MLP-041621

MLP-032482

MLP-035542 to MLP-035667

MLP-037218 to MLP-037527

MLP-038008 to MLP-038989

MLP-039014 to MLP-039945

MLP-040009 to MLP-040896

MLP-041013 to MLP-041589

Product: Heartmate XVE & HeartMate II Apical Coring Knife

Model / REF:

REF: 1050

Lot Numbers:

135021-135025

134241-134246

134248

134250

134251

134240

135060

135061

135062

134247

132849-132853

134239

Serial Range: 132849 to 135062

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92951

Status: Active

Manufacturer: Thoratec Corp.

Sold By: Direct distribution to hospitals and medical facilities

Manufactured In: United States

Units Affected: 2,681

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

Agency Last Updated: December 15, 2023

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.

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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

What You Should Do

Identify if your device is affected by checking the product packaging for the following Reference (REF) numbers: 106524US, 106524INT, or 1050.

For Heartmate 3 LVAS Implant Kit (REF 106524US), check for serial numbers in these ranges: MLP-034137 to MLP-034744, MLP-035485 to MLP-035714, MLP-036330 to MLP-037708, MLP-038104 to MLP-038999, MLP-039000 to MLP-039999, MLP-040000 to MLP-040999, and MLP-041000 to MLP-041621.

For Heartmate 3 LVAS Implant Kit (REF 106524INT), check for serial numbers: MLP-032482, MLP-035542 to MLP-035667, MLP-037218 to MLP-037527, MLP-038008 to MLP-038989, MLP-039014 to MLP-039945, MLP-040009 to MLP-040896, and MLP-041013 to MLP-041589.

For standalone Apical Coring Knives (REF 1050), check for serial numbers in the range 132849 to 135062, including specific numbers: 135021-135025, 134241-134246, 134248, 134250, 134251, 134240, 135060, 135061, 135062, 134247, 132849-132853, and 134239.

If you are a healthcare provider, ensure a backup coring knife is available and inspected for sharpness before beginning any implantation procedure.

Contact Thoratec Corp. at their Pleasanton, California location or your local representative for more information regarding the voluntary notification letter sent on August 7, 2023.

Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls if you have additional questions or need to report a problem.

Affected Products

Product: Heartmate 3 LVAS Implant Kit

Model / REF:

REF: 106524US

REF: 106524INT

Lot Numbers:

MLP-034137 to MLP-034744

MLP-035485 to MLP-035714

MLP-036330 to MLP-037708

MLP-038104 to MLP-038999

MLP-039000 to MLP-039999

MLP-040000 to MLP-040999

MLP-041000 to MLP-041621

MLP-032482

MLP-035542 to MLP-035667

MLP-037218 to MLP-037527

MLP-038008 to MLP-038989

MLP-039014 to MLP-039945

MLP-040009 to MLP-040896

MLP-041013 to MLP-041589

Product: Heartmate XVE & HeartMate II Apical Coring Knife

Model / REF:

REF: 1050

Lot Numbers:

135021-135025

134241-134246

134248

134250

134251

134240

135060

135061

135062

134247

132849-132853

134239

Serial Range: 132849 to 135062

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92951

Status: Active

Manufacturer: Thoratec Corp.

Sold By: Direct distribution to hospitals and medical facilities

Manufactured In: United States

Units Affected: 2,681

Agency Last Updated: December 15, 2023