Recalls and alerts
A class I recall of the VNS Therapy SenTiva Generator System by LivaNova due to an unintended reset error that causes the system to stop delivering vagus nerve stimulation therapy. The manufacturer has received 14 reports of such errors, and four patients have required early revision surgery for failed devices. No related deaths have been reported. The manufacturer implemented additional mitigations on July 31, 2019, and no reset errors have occurred since then. The recall includes 2,909 devices distributed in the U.S.
An alert that some Level 3 surgical gowns and Presource procedural packs that contain these gowns by Cardinal Health have potential quality issues. Customers should immediately discontinue use of all affected gowns and packs because the manufacturer cannot provide sterility assurance. Instead, clinicians should use FDA-cleared surgical gown alternatives that provide Level 3 barrier protection.
An alert that cybersecurity vulnerabilities in certain Clinical Information Central Stations and Telemetry Servers by GE Healthcare may introduce risks to patients while being monitored. The cybersecurity vulnerabilities identified could allow an attacker to remotely take control of the device to silence alarms, generate false alarms, or interfere with the function of patient monitors connected to these devices. The manufacturer has issued instructions for risk mitigation and how to find software updates or patches when they become available. Clinicians should work with staff at their facilities to determine if a medical device used by patients may be affected and, if so, how to reduce associated risk.
A recall of LemonPrep, PediaPrep, and Wave Prep 4-ounce tubes and single-use cups and Cardio Prep single-use cups by Mavidon due to potential contamination with Burkholderia cepacia. Hospitals, distributors, and clinics that have any of these products should immediately stop using them and quarantine them.
A recall of all unexpired sterile drug products by FUSION IV Pharmaceuticals Inc. (doing business as AXIA Pharmaceutical) due to a lack of sterility assurance. Recalled products have been found to be inconsistent with federal guidelines.
A recall of one lot of lamotrigine tablets (100 mg) by Taro Pharmaceuticals USA Inc. due to cross-contamination. The batch was found to contain a small amount of another drug substance, enalapril maleate, used to manufacture another product at the same facility.
A voluntary field action on specific units of the LIFEPAK 15 monitor/defibrillators by Stryker due to an issue that can cause the devices to fail to deliver a defibrillation shock after the “shock” button is pressed. This is a result of oxidation that may have formed over time within the button on the keypad. The company is contacting customers to schedule the correction of their devices and anticipates that all affected devices will be serviced by June 2021.
A recommendation that hospitals and endoscopy facilities transition away from duodenoscopes with fixed endcaps to those with newer design features that allow for more effective reprocessing. To date, the FDA has cleared a fully disposable duodenoscope and two duodenoscopes with disposable endcaps. The agency is working with manufacturers to increase the supply of duodenoscopes with disposable components and to develop other new and innovative designs that will further minimize or eliminate the risk of patient infection.
The first vaccine (Ervebo) approved for the prevention of Ebola virus disease caused by Zaire ebolavirus. The vaccine is administered to adults as a single-dose injection and is a live, attenuated vaccine that has been genetically engineered to contain a protein from the Zaire ebolavirus. Approval was based on a randomized cluster vaccination study in Guinea during the 2014–2016 outbreak. A total of 3,537 contacts and contacts of contacts of individuals with laboratory-confirmed Ebola virus disease received either immediate or 21-day delayed vaccination. The vaccine was determined to be 100% effective in preventing Ebola cases with symptom onset greater than 10 days after vaccination. There were no Ebola cases with symptom onset greater than 10 days after vaccination in the immediate group, compared with 10 cases in the delayed group. Safety was assessed in about 15,000 individuals in Africa, Europe, and North America. The most commonly reported side effects were pain, swelling, and redness at the injection site, as well as headache, fever, joint and muscle aches, and fatigue.
Ubrogepant (Ubrelvy) tablets for the acute treatment of migraine with or without aura in adults. The drug is the first in the class of oral calcitonin gene-related peptide receptor antagonists approved for the acute treatment of migraine. In two randomized, double-blind, placebo-controlled trials, the percentages of patients who achieved pain freedom two hours after treatment and whose most bothersome migraine symptom stopped two hours after treatment were significantly greater among those who received the drug at all doses compared to those receiving placebo. The most common side effects were nausea, tiredness, and dry mouth. The drug is contraindicated for coadministration with strong CYP3A4 inhibitors. It is not indicated to prevent migraine.