Cook Medical voluntarily recalled all lots of catheters with its Beacon Tip technology.
The recall includes 4,146,309 catheters that are used in angiographic, diagnostic and interventional procedures.
As of May 3, the company had received 30 medical device reports that indicated catheters with the Beacon Tip technology had polymer degradation at the catheter’s tip that caused the tip to fracture and or separate.
Adverse events associated with 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. Device fragments could end up in the vascular system, genitourinary system, or other soft tissues.
“The preliminary investigation into this matter has identified that environmental conditions, such as storage temperature, humidity, the use of Vaporized Hydrogen Peroxide (VHP) for whole-room decontamination within healthcare facilities, may be contributing to the occurrence,” Cook Medical said in a news release. “Cook Medical recognizes that there may be other undetermined contributors to this issue and will continue to investigate. The FDA and other regulatory agencies around the world have been notified of this action.”
In February, Cook Medical voluntarily recalled 360 lots of its single lumen central venous catheters and pressure monitoring sets and trays.