At first, Vincent Karst, 55, was recovering well from his open-heart surgery in March 2015.
He resumed the activities he enjoyed, such as visiting car shows and eating out. But some months later, his condition mysteriously deteriorated. By fall he was so short of breath, nauseated and overwhelmed by fatigue that he needed to be rehospitalized in York, Pa.
There, doctors diagnosed a new problem: a serious mycobacterial infection that was acquired during his surgery, according to his subsequent lawsuit. Aggressive treatment with antibiotics left him with partial hearing and vision loss.
Federal regulators acknowledge they were aware of infections tied to a heart-surgery device used in Karst's operation by the summer of 2014. But they waited 14 months before issuing a public alert about the risks, and it wasn't until last month — more than two years later — that they issued detailed recommendations to hospitals and patients on what to do.
Critics say a swifter response could have saved thousands of patients like Karst from being exposed to potentially deadly bacteria. Some patients fell ill or died without knowing the real cause, doctors say.
Now hospitals, which consider the heater-cooler machines crucial in open-heart surgery, are scrambling for ways to protect patients. And authorities have urged hospitals from New Jersey to California to notify hundreds of people who underwent surgery in recent years that they might be harboring a dangerous infection. Patients have sued, claiming they were infected in Pennsylvania, Iowa, South Carolina and Quebec.
Experts and patient advocates say these cases are only the latest to expose holes in the nation's approach to spotting and responding to dangerous deficiencies in medical devices.
“It's another example of the poor oversight of medical devices and how the industry has accepted infection as the cost of doing business,” said Helen Haskell, founder of the patient advocacy group Mothers Against Medical Error in Columbia, S.C.
About 60 percent of U.S. hospitals that do heart surgeries rely on the Sorin 3T heater-cooler device used in Karst's surgery, which was approved for sale in 2006. But five other manufacturers sell heater-coolers in the U.S., and FDA officials say they share similar design features that make them prone to contamination.