FDA Warns Company About Slow Action On Recalling Faulty Defibrillators
St. Jude Medical did not recall the older devices or alert doctors or patients about the potential problem for years.
The New York Times:
St. Jude Medical Played Down Defibrillator Failures For Years, F.D.A. Says
The medical device maker St. Jude Medical played down the failure of some batteries in its defibrillators, shipping them for years before recalling the devices last fall, according to a warning letter the Food and Drug Administration issued this week. The company, acquired by Abbott Laboratories in January, also failed to tell its own management and a medical advisory board that the battery problems had led to the death of a patient, the agency found. (Thomas, 4/13)
Chicago Tribune:
FDA Warns Abbott On Heart Device Battery Woes, Cybersecurity Risks
The devices, implanted in the chest, can provide pacing for hearts that beat too slowly and deliver shocks to stop dangerously fast rhythms. Normally the devices alert patients, through a series of vibrations in the chest, months before they need to be replaced. Batteries in some of the devices, however, ran out sooner than expected, giving patients, in some cases, as little as 24 hours' notice before the batteries died. (Schencker, 4/13)
In other news on Abbott —
Bloomberg:
Abbott Said To Agree To Buy Alere At Lower Price, FT Reports
Abbott Laboratories agreed to buy Alere Inc. at a lower price than previously offered, ending a legal battle over the merger between the two U.S.-based health-care companies. Abbott will buy Alere for $51 per share, the companies said Friday in a statement. The new transaction values Alere’s equity at $5.3 billion, or 8.6 percent less than its initial offer. The companies said they expect the deal to close by the end of third quarter, pending shareholder and regulatory approval. (Robinson, 4/14)
