These safety communications were recently posted by the Food and Drug Administration (FDA):
Medtronic ICD and CRT-D Recall
The FDA has announced a Class I recall of Medtronic’s Evera and Visia implantable cardioverter defibrillators (ICDs) and Viva, Claria, Amplia, and Compia cardiac resynchronization therapy defibrillators (CRT-Ds). Medtronic is recalling specified ICDs and CRT-Ds due to an unexpected and rapid decrease in battery life. The decrease in battery life is caused by a short circuit and will cause some devices to produce a “Recommended Replacement Time” (first warning that the battery is low) earlier than expected. Some devices may progress from “Recommended Replacement Time” to full battery depletion within as little as 1 day. If the user does not respond to the first warning, the device may stop functioning. The likelihood that this issue will occur is constant after approximately 3 years after device use. There have been 444 complaints regarding these devices. No deaths have been reported. More Information.
Smisson-Cartledge Biomedical ThermaCor 1200 Disposable Set Recall
The FDA has announced a Class I recall of the ThermaCor 1200 Rapid Thermal Infusion System Disposable Sets because the cassette may leak aluminum into the fluids and expose patients to high levels of the metal. The recall is specific to the disposable cassette portion of the device, not to the full pump. Exposure to high levels of aluminum ions could cause serious patient harm, such as bone or muscle pain and weakness, anemia, seizures, or coma. There have been no complaints, reports of injuries, or deaths related to this device issue. More Information.
FDA Recommends Pause in the Use of Johnson & Johnson COVID-19 Vaccine
The FDA and the Centers for Disease Control and Prevention (CDC) are reviewing data involving 6 reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the Johnson & Johnson COVID-19 vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All 6 cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. The CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. The FDA will review that analysis as it also investigates these cases. Until that process is complete, the FDA is recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot. More Information.