The Indiana medical device giant said its voluntary recall of the FluoroSet radiographic tubal asssessment Set, Kumpe access catheter and Selective salpingography catheter with Beacon tip was prompted by increased reports of “polymer degradation of the catheter tip” resulting in tip fracture and/or separation.
“Our preliminary investigation into this matter has identified that environmental conditions, such as storage temperature, humidity, and the use of Vaporized Hydrogen Peroxide (VHP) for whole-room decontamination within healthcare facilities, may be contributing to the occurrence,” the company wrote in an April 21 letter advising customers of the recall.
“We also recognize that there may be other undetermined contributors to this issue and continue to investigate,” Cook Medical wrote. “Potential adverse events that may occur as a result of catheter polymer degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications may include device fragments in the genitourinary system.”
The letter did not indicate whether any injuries or deaths were reported as a result of the problem. The recall involves all lots of the affected devices.