Customers have experienced issues retrieving or removing the system’s Tack implant. These issues have resulted in 20 reported injuries, according to a March 3 update from the FDA.
There have been no reports of death, but use of the system may risk serious short- and long-term adverse health consequences, the agency said.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
