FDA announces Class 1 recalls for ventilators, LVAS monitors

Editor's Note

The US Food and Drug Administration has announced class 1 recalls—the most severe category indicating risk of serious injury or death—for Abbot Medical’s HeartMate System Monitor and Philips Respironics OmniLab Advanced+ (OLA+) ventilator.

According to the agency’s June 28 report, the recall of the HeartMate System Monitor, part of HeartMate left ventricular assist system (LVAS), was prompted by screen freezing, overlapping buttons or screens, unresponsive buttons, distorted images, and wrong or missing information, any of which could result in inadvertent changes to pump settings. Hemodynamic compromise caused by a pump stop can result in stroke, irreversible brain damage, heart or organ failure or death. So far, 14 injuries and no deaths have been reported.

Also on June 28, an FDA report revealed that Philips Respironics is updating use instructions a for the OmniLab Advanced+ (OLA+) ventilator due to a failure in an inoperative alarm that can interrupt or stop therapy. Stopping therapy can result in anxiety, confusion/disorientation, increased/decreased respiratory rate (RR), dyspnea, tachycardia, abnormal chest wall movement, mild to severe hypoxemia/low oxygen saturation, hypercarbia/respiratory acidosis, hypoventilation, respiratory failure, or potentially death in the most vulnerable patients, the agency reports.

If a software patch does not address the issue, the company says it will offer a replacement device. There have been 15 injuries and one death reported so far.