Medtronic recalls four medical devices due to potentially fatal design flaws

by Michael Heygood

Medtronic issued a series of Class 1 Recalls during the month of June because of problems with medical devices that could pose a risk to patients. A Class 1 recall involves “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

The list of medical devices recalled by Medtronic includes:

Medtronic Xomed NIM Trivantage EMG Endotracheal Tube

Medtronic recalled its Xomed NIM Trivantage EMG Endotracheal Tube on June 21, 2013. The NIM Trivantage Endotracheal Tube allows medical professionals to monitor voice box, or laryngeal, muscles during surgery, keeping the patient’s airways open for ventilation and electromyography (EMG) monitoring when connected to an EMG monitor.

According to a warning issued by the Food and Drug Administration, “cuff leak” or “cuff deflation” could occur with the NIM Trivantage Endotracheal Tube when the inflation valve cap is inappropriately pulled off rather than being snapped-off sideways. If not promptly addressed, the FDA warns that this could result in “serious adverse health consequences” for the patient, “including death.”

Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps

On June 28, 2013, Medtronic recalled its SynchroMed II and SynchroMed EL Implantable Infusion Pumps, which are designed to administer drugs for cancer, chronic pain, and severe spasticity to a specific site inside the patient’s body.

The FDA identified two problems that forced Medtronic to recall the SynchroMed Implantable Infusion Pumps. Patients treated with the pumps may receive medication at a higher- or lower-than-intended rate of infusion in the cerebrospinal fluid (CSF) during the “priming bolus procedure.” This could result in a drug overdose or under dose, putting patients at risk of respiratory depression, coma, or death.

The FDA also warned about a risk of electrical shorting with the SynchroMed infusion pumps. An electrical short circuit in these devices could lead to a loss of or reduction in therapy, which could result in the return of underlying symptoms or withdrawal symptoms, leading to serious adverse health consequences, including death.

Medtronic Sutureless Connector Intrathecal Catheter Products

Medtronic also announced the recall of its Sutureless Connector Intrathecal Catheter in June 2013 after it was redesigned to reduce the chance of occlusion, the blockage or total stoppage of drug flow due to misalignment at the point where the catheter is connected to an implantable pump. Medtronic warned health professionals not to use the older design of its Sutureless Connector Intrathecal Catheter Products because of the risk for occlusion, which could lead to patients receiving too little of their medication, loss of symptom relief, withdrawal symptoms, or death.

Medtronic MiniMed Paradigm Insulin Infusion Sets

Medtronic announced the recall of its MiniMed Paradigm Insulin Infusion Sets on June 7, 2013 because of a safety issue that could occur if fluids such as insulin come in contact with the inside of device’s tubing connector. This problem could temporarily block the vents that allow the pump to be primed, causing patients to receive too much or too little insulin. The FDA warned that problems with the MiniMed Paradigm Insulin Infusion Sets could result in hypoglycemia or hyperglycemia, leading to serious illness.

Heygood, Orr & Pearson and Product Liability Claims

Patients who have been injured by problems with a Medtronic medical device or other defective products may wish to speak with an attorney about filing a product liability lawsuit against the manufacturers of these devices. The lawyers at Heygood, Orr & Pearson have the trial experience, knowledge, and legal expertise to pursue a product liability or personal injury claim against any company whose defective products cause serious injury or death.

Our law firm has tried hundreds of cases to verdict and has settled hundreds more. We not only have the financial resources to take a case to trial, but the legal expertise to ensure that your legal rights are protected in a court of law.

For a free legal consultation about your case and to find out more about filing a lawsuit, contact the law office of Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001. You can also reach us by filling out the free case evaluation form located at the top of this page, and one of our staff members will be in touch with you as soon as possible to discuss your situation.

by Michael Heygood

Michael Heygood is a licensed attorney and partner at HO&P who focuses on insurance and corporate litigation, and other civil arenas. Michael has been named multiple times to the Super Lawyers List.