Medical device recalls, whether voluntary or mandated by the FDA, ensure patient safety.
Here are four medical devices recalls that have been reported since mid-December:
1. WIRION recalled 697 embolic protection devices on Jan. 1 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.
2. Medtronic recalled 943 units of its Synergy Cranial and StealthStation S7 Cranial Software on Jan. 6 due to potential inaccuracies caused by the Biopsy Depth Gauge Cycle View. There have been four complaints regarding this device issue. There have been no reported injuries or deaths.
3. Covidien recalled 135 ventilators on Jan. 3 because of a capacitor manufacturing assembly error that may cause the ventilator to become inoperable or stop working as intended. There have been six complaints and one death. There have been no reported injuries.
4. The U.S. Consumer Product Safety Commission recalled around 377,000 portable bed rails from Middleburg Heights, Ohio-based Compass Health and Orlando, Fla.-based Essential Medical Supply in two separate Dec. 22 announcements.