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.