HEALTH NEWS : FDA Announces Recall of Heart Device Warning of ‘Serious Injuries or Death’

 The U.S. Food and Drug Administration (FDA) announced the recall of Abbott’s HeartMate 3 system after two deaths and dozens of injuries were reported, noting that “serious injuries or death” could be associated with the heart device.

The current recall is the second one announced by the FDA for the HeartMate 3 left ventricular assist device implant kits. The agency also announced a previous recall for Abbott’s HeartMate Touch System.

Abbott said it is recalling the HeartMate 3 products “after complaint reviews identified blood leakage or air entering the seal interface between the left ventricular assist device inflow cannula and the apical cuff.

“In all reported events, the issue was observed during implantation of the device. Blood leakage or air entering the LVAD from this location will impact the integrity of the blood flow and may lead to longer than expected surgery, bleeding (hemorrhage), right heart failure, or air embolism,” the notice said.

The company reported two deaths, 70 injuries, and 81 “incidents,” adding that “use of these devices may cause serious injury or death,” according to the notice. In March, Abbott sent out a device notification letter to customers recommending that standard surgical processes and the instructions for use should be followed if there is a blood leak or air entrapment.

Abbott also advised on how to deal with the air leaks or any surgical bleeding, including “adjusting the pump position, waiting for the natural tendency of blood to coagulate or upon reversal of anticoagulation, adding surgical materials, and exchanging the apical cuff, the pump, or both.”

Other Recalls

Meanwhile, the FDA last week announced the recall of a ventilator due to a power malfunction issue that could cause “serious injuries or death.”

The Trilogy EVO, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal ventilators are made by Philips Respironics, Inc., according to the notice from the FDA. They were assigned a Class I recall by the agency, which is the most serious type.

According to the notice, the software on the respirators has an issue, and they need an immediate update before they can be safely used. The products are designed to be used for people who need breathing assistance, providing either continuous or intermittent breathing assistance.

The company said it told customers to update to the latest software version due to a “possible power malfunction” in the ventilators. Because of the problem, the devices may issue a “loss of power” or “battery depleted” alarm even though sufficient power is still available, “resulting in a sudden loss of ventilation while the device alarms,” it added.

“The use of the affected ventilators may result in ventilator power down and no delivery of therapy to the patient, even though the battery is not depleted,” the notice said. “This could cause serious adverse health consequences, including hypoventilation and death.”

As of May 13, there were no reports of deaths or injuries associated with the recalled products, according to the notice.

Earlier this month, meanwhile, the FDA announced that the 2.7 version of the Apple iOS t:connect mobile app used with the t:slim X2 insulin pump with Control-IQ technology is under a Class 1 recall. The device’s use could result in injury or death, the notice said.

“Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia or even diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugars and lack of insulin,” the notice said.

There have been 224 reported injuries so far. No deaths have been reported.

Tandem Diabetes Care, the maker, urged people to monitor the battery levels to make sure the pump is charged. Consumers should also carry backup supplies of insulin delivery if the pump fails, according to the notice.- Jack Phillips/theepochtimes