News | Ventricular Assist Devices (VAD) | June 08, 2022

Medtronic Recalls HVAD Pump Implant Kit for Pump Weld Defect

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

The U.S. Food and Drug Administration (FDA) has issued a release stating that Medtronic is recalling the HVAD Pump Implant Kit due to a pump weld defect.

June 8, 2022 — The U.S. Food and Drug Administration (FDA) has issued a release stating that Medtronic is recalling the HVAD Pump Implant Kit due to a pump weld defect. Following an inspection of explanted pumps returned to Medtronic, an analysis showed moisture had entered the center post of the pump causing corrosion and demagnetization of the internal magnets, which may cause the pump to rotate incorrectly.

This issue can lead to pump malfunction, death, or severe injury (for example: shock with severe organ dysfunction, stroke), or require patients to undergo major surgery to replace the pump.

The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

  • Product Name: HVAD Pump Implant Kit
  • Models: 1101, 1103, 1104, 1104JP, MCS1705PU
  • Distribution Dates: October 11, 2006 to June 3, 2021
  • Devices Recalled in the U.S.: 1,614
  • Date Initiated by Firm: April 11, 2022

Device Use

The HeartWare Ventricular Assist Device (HVAD) System is used to help the heart continue to pump blood to the rest of the body. The HVAD system is used as a bridge to cardiac transplants in patients who are at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy (DT) in patients for whom heart transplants are not planned.

Reason for Recall

Medtronic is recalling the HVAD Pump Implant Kit due to a pump weld defect. Following an inspection of explanted pumps returned to Medtronic, an analysis showed moisture had entered the center post of the pump causing corrosion and demagnetization of the internal magnets, which may cause the pump to rotate incorrectly. Patients with affected devices may present with signs and symptoms that resemble pump thrombosis.

If this issue occurs, it may lead to pump malfunction, death, or severe injury (for example: shock with severe organ dysfunction, stroke), or require patients to undergo major surgery to replace the pump.

Medtronic has received three complaints regarding this device issue, including one death, and two injuries.

Who May be Affected

  • Health care providers using the Heartware HVAD System
  • Patients who have procedures with the Heartware HVAD System

What to Do

On April 11 2022, Medtronic sent an Urgent Medical Device Correction letter to select physicians and health care providers who have unused HVAD Pump Implant Kits to request that the product be returned.

On April 26, 2022, Medtronic sent an Urgent Medical Device Correction letter to all physicians and health care providers to inform them of this potential pump weld defect.

The letter requested customers to:

  • Upload and submit all .csv logfiles to Medtronic when patients present with the signs and symptoms listed in the letter.
  • Consider whether patients presenting with any of the signs and symptoms listed in the letter could be caused by a pump thrombus and treat accordingly. Physicians should make decisions about removing or exchanging the pump on a case-by-case basis, considering the patient's clinical condition and surgical risks.
  • Share the letter with all those who need to be aware within their organization or any organization where potentially affected patients have been transferred.
  • Complete the enclosed Customer Confirmation Form and email to [email protected].

Contact Information

Health care providers with questions about this recall should contact their local Medtronic Representative.

Patients with questions about this recall should contact Medtronic Patient Services at 800-635-3930 (Monday-Friday, 8 a.m. to 5 p.m. Central time).

Related HVAD Content:

Medtronic Recalls HVAD Pump Implant Kits After 2 Deaths and 19 Serious Injuries

Class I Recall Issued for Medtronic HeartWare HVAD Pump

Medtronic HeartWare HVAD System Approved for Destination Therapy

FDA, Medtronic Expand HeartWare VAD Recall, Announces New Recall of VAD Component

FDA Announces Two HeartWare HVAD System Class 1 Recalls

New Heart Assist Pump Allows Minimally Invasive Approach at Vanderbilt Heart and Vascular Institute


Related Content

News | Heart Failure

February 15, 2024 — Canary Medical, a medical data company focused on the development and commercialization of its ...

Home February 15, 2024
Home
News | Heart Failure

February 12, 2023 — A team at Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital has successfully ...

Home February 12, 2024
Home
News | Heart Failure

January 30, 2024 — Researchers from the Johns Hopkins Bloomberg School of Public Health have developed a single ...

Home January 30, 2024
Home
News | Heart Failure

January 23, 2024 — Sequana Medical NV, a pioneer in the treatment of fluid overload in liver disease, heart failure and ...

Home January 23, 2024
Home
News | Heart Failure

January 16, 2024 — Cardiac Dimensions, a leader in the development of innovative and minimally invasive treatment ...

Home January 16, 2024
Home
News | Heart Failure

November 30, 2023 — BioCardia, Inc., a developer of cellular and cell-derived therapeutics for the treatment of ...

Home November 30, 2023
Home
News | Heart Failure

November 30, 2023 — Sequana Medical NV, a pioneer in the treatment of fluid overload in liver disease, heart failure and ...

Home November 30, 2023
Home
News | Heart Failure

November 16, 2023 — Mount Sinai’s Cardiovascular Research Institute is sending bioengineered human heart muscle cells ...

Home November 16, 2023
Home
News | Heart Failure

November 16, 2023 — A smartphone app using artificial intelligence technology to detect changes in the voice of a person ...

Home November 16, 2023
Home
News | Heart Failure

November 14, 2023 — Deepak Srivastava, MD, president of Gladstone Institutes and a renowned cardiovascular researcher ...

Home November 14, 2023
Home
Subscribe Now