News | Ventricular Assist Devices (VAD) | May 29, 2020

Class I Recall Issued for Medtronic HeartWare HVAD Pump

Outflow graft and strain relief recalled due to risk of breaks and tears during set up

FDA Class I Recall Issued for Medtronic HeartWare HVAD Pump

May 29, 2020 — Medtronic is recalling its HeartWare HVAD left ventricular assist device (LVAD) pump outflow graft and outflow graft strain relief because it may tear and the strain relief screw may break during assembly prior to implant. Medtronic said the issues might not be observed until during or after the pre-implant pump assembly and attachment to the HVAD pump.

Medtronic has received 92 complaints related to the pre-implant pump assembly process, which includes both the strain relief screw breaking and outflow graft tears. The recall in the U.S. includes 4,924 devices. The recall was initiated April 3, 2020,

The FDA says this is a Class I recall because use of these affected products may cause serious patient harm including dizziness, loss of consciousness, bleeding, fluid buildup around the heart, additional medical procedures or even death.

Read the FDA recall

The recalled medical products include:
   • HVAD Pump Outflow Graft: 1125
   • HVAD Pump Implant Kit: 1103
   • HVAD Implant Accessories Kit: 1153

The HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief, are parts of the HeartWare Ventricular Assist Device (HVAD) System, that help the heart deliver 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 where new transplants are not planned.

 


Related Content

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
News | Heart Failure

November 13, 2023 — Ultromics, a leading health technology company at the forefront of detection of heart failure and ...

Home November 13, 2023
Home
News | Heart Failure

November 3, 2023 — The national Board of Directors of the American Heart Association last week voted to provide full ...

Home November 03, 2023
Home
News | Heart Failure

October 20, 2023 — An international team of scientists has identified nearly a dozen genes that contribute to calcium ...

Home October 20, 2023
Home
News | Heart Failure

October 18, 2023 — Sequana Medical NV, a pioneer in the treatment of fluid overload in liver disease, heart failure and ...

Home October 18, 2023
Home
Subscribe Now