News | Ventricular Assist Devices (VAD) | September 18, 2015

SynCardia Systems Issues Class I Recall of Freedom Driver System

Part failure on drive mechanism for Total Artificial Heart could cause device to stop pumping, resulting in serious injury or death

Freedom Driver, SynCardia, recall, Total Artificial Heart, TAH-t, part failure

Freedom Driver attached to Total Artificial Heart. Image courtesy of SynCardia.

September 18, 2015 — SynCardia Systems initiated a Class I recall of the Freedom Driver Systems used with the company’s temporary Total Artificial Heart (TAH-t) on Aug. 6, 2015. The recall focused on a specific part of the Freedom Driver drive mechanism that the company said may fail and cause the device to stop pumping.

The SynCardia TAH-t is a mechanical replacement for a patient’s heart, used in patients at risk of imminent death from heart failure who are waiting for a heart transplant. It is a pump that is implanted into the chest to replace the bottom half of a patient’s heart (left and right ventricles). The device is sewn to the remaining top half of the patient’s heart (atria). The Freedom Driver system is attached to the TAH-t pump and operates and monitors the device.

SynCardia noted that patients do not receive any advance warning that the device may fail. If it does fail, a red light located in the center of the driver, toward the top, will stay red and a loud continuous alarm will sound.

However, if the Freedom Driver stops pumping, the patient will lose consciousness almost immediately, which means that the warning light and alarm may not be helpful. The patient will likely experience serious injury or death if not immediately switched to a backup driver by a caregiver.

In the Urgent Medical Device Recall Letter, SynCardia told customers they would notify all hospitals that have the affected drivers — in lot numbers 85978 (serial numbers 85978-001 through 85978-040) and 85979 (Serial Numbers 85979-001 through 85979-040) — and replace the drivers with new ones. Additionally, SynCardia informed customers to:

  • Notify any patients with an affected device and exchange the driver;
  • A SynCardia representative will assist with replacement and return of the product; and
  • Return affected Freedom Drivers and complete the Recall Acknowledgement and Receipt Form attached to the letter.

For more information: www.fda.gov/medwatch

Related Content

Some of the new devices technologies to treat heart failure that are either in clinical trials or were recently cleared by the U.S. FDA. #heartfailure

Some of the new devices technologies to treat heart failure that are either in clinical trials or were recently cleared by the U.S. FDA. 

Feature | Heart Failure | February 21, 2020 | Dave Fornell, Editor
There are several new tools being added to the clinical armamentarium in the fight against...
Tufts Medical Center created a heart failure team approach to care for its patients. The program includes an interventional heart failure fellowship program, where interventional cardiologists learn more advanced care, as show here with an ECMO procedure being performed in a cath lab at Tufts. The interventional cardiologists learn how to better care for heart failure patients and interface with surgeons, intensivists and others on the HF care team. The operator is Nevin Kapur. Photo by Dave Fornell.

Tufts Medical Center created a heart failure team approach to care for its patients. The program includes an interventional heart failure fellowship program, where interventional cardiologists learn more advanced hemodynamic support methods, as shown here with an ECMO procedure being performed in a cath lab at Tufts. The interventional cardiologists learn how to better care for heart failure patients and interface with surgeons, intensivists and others on the HF care team. Photo by Dave Fornell.

Feature | Heart Failure | February 20, 2020 | Dave Fornell, Editor
There is no, single magic bullet in heart failure (HF) to easily reduce readmission rates or easily reverse this...
he U.S. Food and Drug Administration (FDA) has approved Carmat's investigational device exemption (IDE) application to start a U.S. early feasibility study (EFS) of its total artificial heart.
News | Heart Failure | February 12, 2020
February 12, 2020 — The U.S.
 Revivant TC
News | Heart Failure | December 18, 2019
December 18, 2019 — BioVentrix, Inc., developer of the first less
 impulse dynamics Optimizer for Heart failure.
News | Heart Failure | December 12, 2019
December 12, 2019 — Impulse Dynamics, developer of Optimizer Smart System
The Cordella Pulmonary Artery Pressure Sensor System for Heart failure. #AHA19 #AHA
News | Heart Failure | November 21, 2019
November 21, 2019 — Endotronix, a digital health and medical technology company dedicated to advancing the treatment
Heart failure VICTORIA TrIal a success. Dave Fornell
News | Heart Failure | November 21, 2019
November 21, 2019 — Merck announced the results from the Phase 3 VICTORIA Study evaluating the efficacy and safety of
The U.S. Food and Drug Administration (FDA) has granted market clearance for AstraZeneca's dapagliflozin (Farxiga) to reduce the risk of hospitalization for heart failure (HF) in adults with type 2 diabetes (T2D) and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.
Feature | Heart Failure | October 21, 2019 | Dave Fornell, Editor
October 21, 2019 – The U.S.
Research Shows Drug Can Extend Survival Rates for Heart Failure Patients
News | Heart Failure | October 16, 2019
Researchers have shown for the first time in preclinical studies that the drug Aliskiren can delay the progression of...
Overlay Init