On April 12, 2017, Abbott Laboratories received a letter from the U.S. Food and Drug Administration warning them about manufacturing flaws regarding several cardiovascular devices acquired through their January 2017 purchase of St. Jude Medical for $25 billion.
The FDA stated that the company failed to disclose at least one death that was associated with one of the defective cardiovascular devices and that an inspection in a California facility raised troubling questions about the safety of several defibrillators and portable heart monitors.
The inspection uncovered dangerous leaking of lithium batteries in a number of devices and a serious underestimation of the occurrence of the dangerous situation.
Abbott released a statement claiming a “strong history and commitment to product safety and quality.” The company also stated that the inspection took place in February and that the issues raised were addressed in a March 13th letter to the FDA which described all corrective actions taken.
“We take these matters seriously, continue to make progress on our corrective actions, will closely review FDA’s warning letter, and are committed to fully addressing FDA’s concerns,” the company said.
The FDA stated that Abbott failed to provide evidence that the corrective actions they claimed to implement were actually implemented.
The devices affected by the leakin lithium batteries – implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) – help regulate heart rhythms.
In October, before they were acquired by Abbott Laboratories, St. Jude said it would recall certain devices due to battery failure caused by lithium leakage. Abbot Laboratories has not moved forward with that recall.
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