FDAnews Device Daily Bulletin

FDA Warns Abbott Over Defibrillator Manufacturing Issues

April 18, 2017

The FDA has issued a warning letter to Abbott citing serious CAPA and other violations at its St. Jude Medical defibrillator manufacturing facility in Sylmar, Calif.

During a Feb. 7-17 inspection, the agency found the firm underestimated the problem of premature battery drainage on some devices, and continued to ship the devices.

The agency says Abbott shipped 10 implantable cardiac defibrillators from one of its distribution centers despite a recall of its Fortify, Unify, and Assura products because of the battery drainage problem.

The company repeatedly concluded that the cause of the battery draining “could not be determined” although a supplier’s analysis indicated the problem was caused by shorting of the lithium clusters.

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