Covidien Defibrillation Electrodes: FDA Class 1 Safety Alert

Covidien Components of Defibrillators May Cause Organ Failure, Strokes or Death

The FDA has issued a Class 1 safety alert for the electrodes used in defibrillator medical devices listed below. A Class 1 alert is the most serious issued by the FDA.

The concern is that devices using Covidien electrodes may delay or fail to activate the electrical shock used to restart the heartbeat of patients during heart attacks, leading to strokes, organ failure or death. Reports of the delay when trying to restart the hearts of two patients resulted in one death. Continue reading “Covidien Defibrillation Electrodes: FDA Class 1 Safety Alert”

VIDEO: Medtronic Pump Lawsuit Advances, U.S. Supreme Court Denies Mfr. Appeal

The U.S. Supreme Court refuses an appeal from medical device manufacturer Medtronic in a liability lawsuit filed by an Arizona man allegedly left paralyzed by a Medtronic pain pump.

In a related Medtronic matter, Attorney Matt Harman discusses a lawsuit filed on behalf of a mother claiming her daughter died due to a defect and malfunction of her Medtronic insulin pump, prior to the manufacturer providing the FDA with information that later led to a Class 1 recall: Continue reading “VIDEO: Medtronic Pump Lawsuit Advances, U.S. Supreme Court Denies Mfr. Appeal”

FDA: Blood Vein Filters (IVC’s) Could Cause Life Threatening Damage or Death

Concerns prompt FDA to issue additional safety alert


The FDA issued a “Safety Communication” May 6, 2014 regarding the potential for harm to patients from a small, cage-like medical device implanted in blood veins. The device, the Interior Vena Cava (IVC) filter, is used in patients at risk of developing blood clots or embolisms anywhere in the body, but especially in their legs (which is called deep vein thrombosis). The filter device is an option for patients who cannot take blood thinners. Blood clots and embolisms can travel to heart, lungs, and other organs, causing serious damage or death. Continue reading “FDA: Blood Vein Filters (IVC’s) Could Cause Life Threatening Damage or Death”

Heartware Ventricular Assist System Pump Connector Failure Could Lead to Death: Manufacturer Reissues Warning Following FDA Class 1 Recall Issued

Followup to December 2013 Class 1 recall of the HeartWare, Inc. Heartware Ventricular Assist System

In December of last year, the FDA issued its most serious recall, Class 1, for the HeartWare, Inc. “Heartware Ventricular Assist System” pump mechanism. The manufacturer followed up yesterday by reissuing a warning to physicians following additional reports of device failure. Continue reading “Heartware Ventricular Assist System Pump Connector Failure Could Lead to Death: Manufacturer Reissues Warning Following FDA Class 1 Recall Issued”

Philips Brand Trilogy Ventilator Recall: Failure Could Cause Serious Injury or Death

Trilogy Ventilator power management boards have been recalled due to a failure in the system that could interrupt or stop the mechanical breathing in the continuous or intermittent ventilator support for patients.

Medical equipment for resuscitation in operating-room

The failure in the Philips Brand Trilogy Ventilator could lead to serious injury or death. Continue reading “Philips Brand Trilogy Ventilator Recall: Failure Could Cause Serious Injury or Death”

Harman & Fredrickson CLE: The Shifting Landscape of Medical Device Preemption

At the 22nd Annual Product Liability Seminar Continuing Legal Education (CLE) of the State Bar of Georgia, attorneys Matt Harman and Eric Fredrickson prepared a session on medical device preemption. Eric Fredrickson presented the information to the assembled attorneys on February 26, 2014.

The key takeaway for plaintiff’s attorneys in medical device cases that call preemption into question was:

Continue reading “Harman & Fredrickson CLE: The Shifting Landscape of Medical Device Preemption”

Ventilator Recall: FDA Says Puritan Bennett by Covidien May Stop, Causing Patient Injury or Death

Today the FDA issued and posted a Class 1 recall, the most serious, for the Puritan Bennett 840 Series Ventilator by Covidien saying a software glitch may cause the device to stop working, preventing air from reaching patients who may not be able to breathe on their own and causing serious injury or death. Continue reading “Ventilator Recall: FDA Says Puritan Bennett by Covidien May Stop, Causing Patient Injury or Death”

Class 1 Recall: Hospira Inc., GemStar Infusion System

The FDA has republished a Class 1 recall, the most serious, for the Hospira Inc. GemStar Infusion System.

The GemStar pump by Hospira is designed to deliver fluids via IV, to lower back or spinal areas, and in other parts of the body.  It is small, lightweight and can be portable when using battery power. Designed for use in the hospital, home, or other settings, the electronic infusion system can deliver medications, nutrition, and blood or blood products. Continue reading “Class 1 Recall: Hospira Inc., GemStar Infusion System”

Recall of Medtronic Cardiac “Guidewires”

The FDA has classified the Medtronic cardiac “guidewires” recall as a Class 1, the most serious category.

Medtronic issued a voluntary recall of the “guidewires,” the wire connectors used to connect cardiac devices that help regulate heartbeat and other functions and facilitate heart surgery because the coating on the wire may disintegrate causing the wire to detach and put the patient at risk for injury or death. Continue reading “Recall of Medtronic Cardiac “Guidewires””

Medtronic MiniMed Paradigm Insulin Pump: Lawsuit Filed

The Harman Law Firm has filed a complaint against the manufacturer of the Medtronic MiniMed Paradigm MMT 722 Insulin Pump following the death of a young woman who was using the device


The MiniMed Insulin Pump is designed to deliver insulin continuously into the body, making multiple injections per day unnecessary. The young college student with the MiniMed pump died from “diabetic ketoacidosis,” a condition that results from uncontrolled blood sugar that can quickly lead to heart failure, kidney failure, coma or death.
Continue reading “Medtronic MiniMed Paradigm Insulin Pump: Lawsuit Filed”