Boston Scientific Corp. put a pair of its cardiac rhythm devices on the market in Japan.
The Natick, Mass.-based medical device-making monolith said it launched its Cognis cardiac resynchronization therapy defibrillator and Teligen implantable cardioverter defibrillator in the Land of the Rising Sun, after landing approval from the Japanese Ministry of Health, Labor and Welfare in August and reimbursement approval in September.
BSX touts the devices as “the world’s smallest and thinnest high-energy devices.” In March, the company sent a letter to physicians warning that faulty wiring in 15 of the devices delivered “inappropriate” shocks to patients’ hearts. Up to 8,000 of the 34,000 patients implanted with the devices at the time could have been at risk, according to the letter. No deaths were reported because of the malfunctions and there were no recall plans.
Company spokesman Dave Knutson told MassDevice that the porblem has since been corrected.
“We have developed software that has eliminated that risk and we have updated all of our programmers in the United States,” Knutson told us, explaining that th eprogrammers are devices that communicate with the Cognis and Teligen defibrillators. “That corrected software was already in Japan.”