The FDA recalled the catheter included in the Fuhrman Pleural/Pneumopericardial Drainage Set, which is used to remove air from the pericardium surrounding the heart or drain fluid from the pleural cavity that protects the lungs.
The class I recall, which is the most serious type of recall, occurred after Stryker Sustainability Solutions received two reports that the catheter broke off in the patients’ pleural cavity when physicians inserted the device, according an FDA safety alert.
The FDA said that medical intervention was needed in both cases and that the issue could cause serious injury or death.
The recall included 34 devices in the U.S. that were manufactured from Nov. 6, 2009, to Oct. 21, 2011, and distributed from Dec. 12, 2009, to Oct. 28, 2011, in Alaska, California, Wisconsin, Indiana, Florida, Oregon, New York and North Carolina.
Stryker Sustainability Solutions said customers should stop using the devices immediately and would receive credit for devices returned.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.