Datascope Issues Field Correction For Selection of Intra-Aortic Balloon Pumps Due to Potential Electrical Test Failure Code
Datascope Corp. recently initiated a voluntary field correction of certain Intra-Aortic Balloon Pumps (IABPs) due to a potential electrical test failure code. The field correction also includes all System 98 or System 98XT IABPs that were converted to a CS100i or CS300 IABP. Datascope issued the field correction following the receipt of a complaint related to a patient death after the device experienced an electrical test failure code and failed to initiate therapy. Affected units were distributed between March 23, 2003, and Dec. 11, 2013, totaling approximately 12,000 units globally. Patients with IABPs are not in stable condition and sudden interruption of therapy may result in unsafe circumstances. Health care professionals are encouraged to assess the risk-benefit for each patient when no alternative therapy is available and follow recommended instructions for using affected units. Read the full announcement and recommendations from the U.S. Food and Drug Association here.
Keywords: Heart-Assist Devices, Risk Assessment, United States Food and Drug Administration
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