Medtronic Cobalt and Chrome Heart Implants Recalled Due to Shock Failure Risk

Nearly 90,000 Medtronic cardiac defibrillators may fail to provide sufficient electrical shock therapy when needed, which can lead to irregular heartbeats and life-threatening heart problems, federal regulators warn in a recently-announced recall.

The U.S. Food and Drug Administration announced a Medtronic Cobalt/Crome IDC and CRT-D recall on August 19, indicating that the devices may malfunction, resulting in a short circuit protection (SCP) alert that reduces the electrical shock delivery necessary to correct an irregular heartbeat.

The recall impacts Medtronic Cobalt XT, Cobalt and Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), which are implantable devices that delivery electrical shock therapy to correct a slow heartbeat or to restore a regular heartbeat if a life-threatening arrhythmia occurs.

However, defects with the defibrillators may result in reduced-energy electrical shocks, which fail to treat an irregular heartbeat or may cause patients to develop an irregular heartbeat. Officials warn those who suffer from arrhythmias and do not receive the proper shock therapy treatment could be at an increased risk serious injury or death.

Given the serious risk of severe injury or death, the FDA has classified the action as a Class I medical device recall, which is the most serious category.

While no serious injuries or deaths have been confirmed to date, officials have received at least 27 reports of the Medtronic cardiac devices experiencing the short circuit protection (SCP) alert s resulting in reduced electrical shock therapy to patients.

The recalled Medtronic Cobalt/Crome defibrillators were manufactured an distributed to hospital and healthcare facilities nationwide between February 3, 2020 to August 19, 2022.

Medtronic issued a communication to customers on June 22, offering a serious of recommendations and considerations for healthcare providers to take to ensure patient safety. Those recommendations include not preemptively replacing the devices for this recall, and to closely monitor patients with routine follow-ups.

Medtronic provided instructions to customers on what to do until a software update becomes available in late 2022 to correct the issue.

Once the software update becomes available, patients will need to schedule an in-clinic follow-up for their devices to receive the update. “The update will ensure the full shock energy is delivered in the presence of a secondary, low-level current pathway in the high voltage circuitry”, according to the recall.

Customers with additional questions or concerns regarding the recall are encouraged to contact Medtronic Technical Services at 1-800-723-4636 or their local Medtronic representative. The FDA is asking that all adverse reactions or quality problems related to the devices be reported to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Medtronic Pacemaker Recalls and Problems

Medtronic has a long history of problems with defibrillators, cardioverters and specifically their line of recalled HVADs (HeartWare Ventricular Assist Devices)  which have been subject to numerous Class I recalls due to serious and dangerous manufacturing and design defects that have caused thousands of patient fatalities.

The Medtronic HVAD system has been linked to more Class I recalls than any other high-risk medical devices.

In June, a Class I medical device recall for Medtronic HeartWare Ventricular Assist Device (HVAD) System was announced by the FDA, warning that it had received three complaints, including the two patient deaths, linked to pump thrombosis. An analysis of the devices found all three were malfunctioning due to a weld defect which allowed moisture into the devices and corroded magnets keeping an impeller rotating concentrically.

In May, Medtronic issued an HVAD battery defect recall, warning the batteries have been linked to multiple instances of welding defects which could cause the battery to malfunction and no longer hold a charge, no longer completely recharge, or fail to provide power to the life-sustaining device.

Medtronic reported it received two complaints involving three defective HVAD batteries and one patient death. The patient that died had a device where two batteries simultaneously malfunctioned and stopped sending power to the patient’s HVAD device.

A growing number of defective Medtronic medical device lawsuits have been filed in recent years. In June, a Missouri woman filed a wrongful death lawsuit against Medtronic, claiming the defective design of a HeartWare Ventricular Assist Device (HVAD) system caused her husband to suffer fatal injuries after the heart pump malfunctioned and failed to restart.