U.S. FDA warns Abbott Labs over heart device problems

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 1.8 percent to $42.67 in mid-morning trading.

The FDA 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 for patients with cardiac devices remotely.

The FDA investigation showed that lithium batteries in the devices were draining prematurely and that the company had “underestimated the occurrence of the hazardous situation.”

Abbott said in a statement that it has a “strong history and commitment to product safety and quality.” It said the FDA’s inspection of the facility took place in February and that Abbott responded on March 13 describing corrective actions it was taking.

“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 said Abbott had provided implementation dates for several corrective actions but failed to provide evidence that the actions had actually been implemented.

The FDA said the company failed to disclose at least one death associated with the device.

(Reporting by Toni Clarke in Washington; Editing by Bernard Orr)

Read More at Reuters

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