Medical device recalls, whether voluntary or mandated by the FDA, ensure patient safety.
Here are five medical device recalls that have been reported since Jan. 10:
1. Empowered Diagnostics recalled over 284,000 COVID-19 antigen tests and 2,100 antibody tests on Jan. 28 due to the risk of false results. There have been no reports of adverse health consequences or death.
2. Philips Respironics recalled 215 Trilogy EVO Ventilators and 51 Trilogy EVO repair kits on Jan. 26 due to potential health risks from polyester-based polyurethane sound abatement foam. The foam may break down and potentially enter the device's air pathway, causing potential inhalation. There have been no reported injuries or deaths.
3. Medtronic recalled over 95,100 units of the HawkOne Directional Atherectomy System on Jan. 21 due to the risk of guidewire within the catheter moving downward or prolapsing when force is applied during use. There have been 163 complaints, 55 injuries and no deaths reported about this device issue.
4. Getinge USA recalled 50 units of the Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems on Jan. 19 due to the risk of potential chemical breakdown of sevoflurane, a general surgical anesthetic, which may result in inhalation and/or skin exposure to harmful chemicals. There have been eight complaints regarding this device issue, but no reported deaths or injuries.
5. Cardiovascular Systems recalled 697 units of its Wirion embolic protection devices on Jan. 10 because of complaints of filter breakage during retrieval. There have been reports of nine device malfunctions and no reports of death related to the issue.