The U.S. Food and Drug Administration issued a warning letter to Abbott Laboratories, citing manufacturing flaws with a range of cardiovascular devices acquired with its purchase of St. Jude Medical in January for $25 billion.
The letter, dated April 12 and made public on Thursday, sent Abbott’s shares down 2 percent to $42.61.
The FDA, which said the company failed to disclose at least one death associated with one of the devices, said an inspection of the company’s facility in Sylmar, California, raised questions about the safety of several implantable defibrillators and its Merlin@home monitor, which allows doctors to care remotely for patients with cardiac devices.
