![]() The warning has now been elevated to a full recall. The company issued a letter to providers warning them about this issue Nov. Last November, the FDA issued a warning letter explaining it was evaluating reports of Getinge's Maquet/Datascope IABP devices shutting down while running on battery power. The company said the recall includes 22,853 devices in the United States. Maquet/Datascope is aware of five patient deaths since March 2016, although the firm has not concluded that the deaths are due solely to the device shutting down while operating on battery power, the FDA said. The FDA issued a recall notice that said if a patient requires life-supporting therapy with an IABP and the device does not work or if therapy is stopped during use due to battery failure, the patient will be at risk of serious injury, including death. This may cause the device to stop working when being operated by battery only. Food and Drug Administration announced Maquet/Datascope is recalling all intra-aortic balloon pumps (IABP) due to reports of the batteries failing to hold a charge, stopping unexpectedly and having a shortened run-time.
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