Medtronic has announced a recall of its Cobalt and Crome implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators. A report issued by the Food and Drug Administration labeled the recall in the Class I after the report found that the devices may only deliver approximately 79 percent of the intended energy of the shock during high-voltage treatment. The recall includes more than 20,000 units.
The recall comes after healthcare professionals in Europe received an urgent field safety notification from Medtronic last month regarding the same issue with the same product codes. The notification stated that the effectiveness of the defibrillator will decrease to approximately 1 percent when only 79 percent of the intended energy is delivered. If this issue occurs, the devices will immediately transmit a short circuit protection alarm. According to Medtronic, this warning could be misunderstood by medical professionals, resulting in the dangerous and unnecessary replacement of the device or its supporting parts. The device maker believes that the issue will affect 0.18 percent of all products worldwide within 24 months of service life.
In order to address the issue, Medtronic gained CE certification in Europe and FDA clearance in the United States for a software update. The device maker has started rolling out the upgrade to devices that had already been implanted in the middle of August and that newly manufactured devices would have the update pre-installed. The manufacturer advises against removing the device as a preventative measure. Clinicians should only consider replacing a device after monitoring and verifying that a reduced energy event occurred with a medtronic representative. Clinicians should also take into account the 81 percent likelihood of administering further reduced-energy shocks and the anticipation that an update will address the problem this year when deciding whether to replace a device.
The Class I recall is the second of the year for Medtronic who previously recalled approximately 240,000 defibrillators concerning battery life problems after receiving more than 440 complaints and 18 injury reports.