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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Monitoring Devices

Thoratec Corp.: HeartMate Touch Communication System Recalled for Unexpected Pump Failures

Agency Publication Date: February 2, 2024
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Summary

Thoratec Corp. is recalling 1,560 HeartMate Touch Communication Systems, including standard, rental, and HMT1150 models, due to software and controller issues. These issues can cause the life-supporting heart pump to stop or start unexpectedly, which can be life-threatening for patients with a Left Ventricular Assist System (LVAS). The affected units were distributed worldwide and in the United States through December 8, 2023. You should contact your healthcare provider immediately if you use this system for monitoring your heart pump.

Risk

The software and controller systems can malfunction, leading to an unexpected pump start or stop without warning. This poses a critical risk to patients who depend on the pump to circulate blood, potentially leading to serious injury or death.

What You Should Do

  1. Check your HeartMate Touch Communication System to see if it matches Model Numbers HMT1100, HMT1100-R (Rental), or HMT1150.
  2. Identify your device's serial number and compare it against the extensive list of affected numbers provided in the recall, such as DMPV40AAHP83, DMPXQ006HP83, or DMPVJAYAHP51.
  3. Verify the UDI-DI code on your device label: 05415067032058 (HMT1100), 05415067033758 (HMT1100-R), or 05415067032041 (HMT1150).
  4. Contact your healthcare provider or Thoratec Corp. immediately for specific instructions on how to manage your device while a software fix or replacement is coordinated.
  5. Report any adverse events or quality problems to the FDA's MedWatch Program at 1-800-FDA-1088 or online at www.fda.gov/medwatch.
  6. For additional questions, contact the FDA directly at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer mitigation and patient notification

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

Affected Products

Product: HeartMate Touch Communication System
Model / REF:
HMT1100
Lot Numbers:
05415067032058 (UDI-DI)
Date Ranges: Distributed through December 8, 2023
Product: HeartMate Touch Communication System, Rental
Model / REF:
HMT1100-R
Lot Numbers:
05415067033758 (UDI-DI)
Date Ranges: Distributed through December 8, 2023
Product: HeartMate Touch Communication System, HMT1150
Model / REF:
HMT1150
Lot Numbers:
05415067032041 (UDI-DI)
Date Ranges: Distributed through December 8, 2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93697
Status: Active
Manufacturer: Thoratec Corp.
Sold By: Authorized Medical Distributors; Hospitals
Manufactured In: United States
Units Affected: 1,560 systems as of 12/8/2023
Distributed To: Nationwide

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 ยท 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.