Healthcare Economy

America's Unsafe Medical Products

Paul Ausick

The U.S. Food and Drug Administration (FDA) issued two new safety alerts in the past two weeks. Both are recalls, including one Class I recall for a product that may cause serious injury or death.

The FDA issues safety alerts to provide timely new safety information on human drugs, medical devices, vaccines and other products, including biologics, dietary supplements and cosmetics. The alerts are publicly available at the agency’s MedWatch website and contain “actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient.”

The following list includes all Medwatch alerts for 2019 through December 23, 2019. There are several types of alerts, including letters to health care providers, warnings to users, drug safety notices and recalls. The most serious alert is a Class I recall, indicating that continued use of these devices may cause serious injury or death. The 2019 alerts are listed in reverse chronological order, with the most recent listed first. Included are the type of alert and the issue date.

Nerve Stimulator Experiences Unintended Reset Causing System to Stop Stimulation Delivery
> Issue date: December 23, 2019
> Type of alert: Recall

LivaNova is recalling 2,909 of its VNS Therapy SenTiva Generator System because unintended resets cause the system to stop delivering stimulation to the vagus nerve. The company has received 14 reports of unexpected resets and four patients have needed to undergo additional surgery to replace the failed device. This is a Class I recall.

Skin Preparation Products May Be Contaminated
> Issue date: December 20, 2019
> Type of alert: Recall

Mavidon is recalling all lots of Lemon Prep, Pedia Prep, Wave Prep, Cardio Prep Single use cups, Collodions, Collodion Remover, Medical Adhesive Remover, Acetone and all products manufactured by Mavidon immediately due to contamination with multi-drug-resistant Burkholderia cepacia, a bacteria that may cause serious infection. The company has received one report of an adverse event in a newborn related to a product in this recall.

Syringe Pump Battery Alarm Faulty
> Issue date: December 19, 2019
> Type of alert: Recall

Smiths Medical is recalling 627 of its ASD Medfusion 4000 Syringe Pumps sold in the United States between September 2019 and October 31, 2019. A software issue may prevent the low battery alarm from sounding before shutting down the pump. This is a Class I recall.

Serious Breathing Problems Could Affect Users FDA-Approved Drugs to Treat Seizures, Nerve Pain and Restless Legs Syndrome
> Issue date: December 19, 2019
> Type of alert: Safety communication

Patients who use gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who also use opioid pain medicines, among other drugs, may experience serious breathing problems.

Seizure Treatment for Children May Be Contaminated
> Issue date: December 18, 2019
> Type of alert: Recall

Lannett is voluntarily recalling two lots of Levetiracetam Oral Solution, 100 mg/mL, due to contamination with Bacillus subtilis. Levetiracetam is used to treat partial-onset seizures in children one month of age or older.

Ranitidine Treatment May Be Contaminated
> Issue date: December 17, 2019
> Type of alert: Recall

Glenmark Pharmaceutical is voluntarily recalling all unexpired lots of ranitidine tablets, 150 mg and 300 mg, due to possible NDMA contamination.