medical device recall

Patients who rely on implanted equipment to maintain vital organ functions likely live with the constant worry that the device may fail. When a piece of equipment later becomes the subject of a recall concerning a defective medical device, affected patients are forced to undergo additional surgery to remedy the problem, leading to further complications. The most recent recall announcement may impact the lives of many Maine residents.

According to a statement by the Food and Drug Administration, Medtronic, which is one of the largest medical equipment supply companies in the world, issued a voluntary recall of its implantable cardiac defibrillators. These particular devices are surgically placed under patients’ skin and run by batteries. The device has filament wires attached to the heart to sense irregular rhythms. Once an irregular beat is detected, the device is programmed to deliver a stabilizing shock.

However, the recalled devices fail to respond to these heart signals, and patients are not receiving the possibly life-saving shock required to restore their hearts to a normal rhythm. These devices also restart a heart that suffers from cardiac arrest. Patients whose devices are failing are at a high risk of death due to the machine’s failure to operate properly.

Medtronic has listed 48 models included in this urgent recall notice. Patients affected by this recall will require another surgical procedure to remove and replace these devices with a safer model. The devices were manufactured between July 13, 2013, to Aug. 8, 2017. The company has pledged to offer additional warranty coverage to affected patients.

How many patients may have been adversely affected by these particular devices is unknown. According to the statement, an unspecified issue with a gas mixture inside the device may cause failure. Maine residents who suffer harm from any defective medical device may also sustain monetary damages due to additional physical injury. An experienced personal injury attorney could provide information concerning how these patients can seek compensation for those damages by filing a successful civil claim.

Source:, “Medtronic recalls faulty implanted cardiac defibrillators,” Allen Cone, Feb. 27, 2018