News | October 29, 2008

Thoratec Issues Warning For Certain HeartMate II VADs

October 30, 2008 - Thoratec Corp. this week notified healthcare professionals of a worldwide correction of the HeartMate II Left Ventricular Assist System (HM II LVAS), of all serial numbers (having catalog numbers 1355 or 102139), distributed since the beginning of clinical studies in November 2003.

Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the system controller may result in damage that could interrupt pump function, the company said. This may require reoperation to replace the pump, and potentially result in serious injury or death, Thoratec said. The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3 percent at 12 months, 6.5 percent at 24 months, and 11.4 percent at 36 months. Healthcare professionals with patients supported by a HeartMate II LVAS should assess the wear and fatigue of the percutaneous lead and provide proper instruction to patients on the management and care of the lead.

For more information: www.fda.gov/medwatch/safety/2008/safety08.htm#HeartMate

Related Content

Medtronic HeartWare HVAD System Approved for Destination Therapy
Technology | Ventricular Assist Devices (VAD)| October 04, 2017
October 4, 2017 — Medtronic received U.S.
Abiomed Receives FDA PMA Approval for Impella RP for Right Heart Failure
Technology | Ventricular Assist Devices (VAD)| September 28, 2017
Abiomed Inc. recently received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for the Impella RP ...
Abbott Receives FDA Approval for HeartMate 3 Left Ventricular Assist System
Technology | Ventricular Assist Devices (VAD)| August 29, 2017
Abbott announced it has received U.S. Food and Drug Administration (FDA) approval for its Full MagLev HeartMate 3 Left...
Pre-PCI Impella 2.5 Insertion Improves Survival in Left Main Coronary Artery Heart Attacks
News | Ventricular Assist Devices (VAD)| June 30, 2017
Abiomed Inc. announced the recent publication of a peer-reviewed retrospective study on hemodynamic support with the...
Heartware HVAD recall for its ventricular assist device from Medtronic
Feature | Ventricular Assist Devices (VAD)| May 05, 2017
May 5, 2017 — Medtronic Mechanical Circulatory Support is expanding its recall of its HeartWare Ventricular Assist De
Videos | Ventricular Assist Devices (VAD)| April 14, 2017
A discussion with William O'Neill, M.D., FACC, FSCAI, medical director of the Center for Structural Heart Disease at
Henry Ford Hospital, Detroit Cardiogenic Shock Initiative, Impella pump, ACC.17 clinical study
News | Ventricular Assist Devices (VAD)| April 03, 2017
Hospitals can dramatically increase heart attack survival rates in patients suffering cardiogenic shock by providing...
Metro Detroit cardiologists, increased heart attack survival rate, Impella heart pump, Detroit Cardiogenic Shock Initiative
News | Ventricular Assist Devices (VAD)| March 09, 2017
Metro Detroit cardiologists from five health systems have joined together to increase residents’ survival rate from...
Impella 2.5 heart pump, high-risk PCI, HRPCI, acute kidney injury risk, AKI, Circulation Research study, Abiomed
News | Ventricular Assist Devices (VAD)| March 09, 2017
A new study published in Circulation Research finds use of hemodynamic support with the Impella 2.5 heart pump during...
James Ward, LVAD surgery, left ventricular assist device, UAB, University of Alabama at Birmingham
News | Ventricular Assist Devices (VAD)| March 08, 2017
Congestive heart failure patients at the University of Alabama at Birmingham (UAB) now have reason for optimism with a...
Overlay Init