More than 4.1 million catheters manufactured by Cook Medical are being recalled following reports that suggest the devices may fracture or separate at the tips during use, posing a need for medical intervention including emergency removal surgery.
The Cook Medical Beacon Tip Technology catheter recall was announced by the FDA on May 4, following at least 30 Medical Device Reports from physicians claiming the tips of the catheters had broken or separated from the catheter during use. No fatalities have been reported to date, however some of the reported device failures have resulted in emergency removal procedures.
The recalled catheters pose a risk of serious and potentially fatal outcomes for patients in the event that the tip fractures or separates during use. The catheter problems could include loss of device function, separation of a device segment resulting in immediate surgical retrieval or further complications resulting from a separated segment.
The FDA is warning physicians that the fracturing of the Beacon Tip catheters could cause device fragments to enter the vascular system, genitourinary system, of other soft tissues. There is also the risk that the fragments could spread into the vascular system, potentially resulting in an embolism in the heart or lungs, or causing occlusion of blood flow to the patient’s organs.
The recall includes an estimated 4,146,309 catheters with Beacon Tip technology that may fracture or separate at the tip due to polymer degradation caused by several environmental factors including storage temperatures, humidity, and the use of Vaporized Hydrogen Peroxide for whole room decontamination in healthcare facilities. A full list of affected catheters is included in the recall notice.
Cook Medical announced that although the company believes environmental factors are the primary contributing cause, there may be other contributing factors that have not yet been determined. The FDA and Cook Medical will be working jointly to investigate the cause and find a solution.
The Beacon Tip catheters are generally used for peripheral, coronary vascular and genitourinary system procedures performed by trained physicians.
Cook Medical is notifying all of its customers and distributors across the globe by mail with instructions to stop using the devices immediately and quarantine all potentially affected units and return them to Cook Medical as soon as possible for a credit. Customers with further questions may contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235 or by email at CustomerRelationsNA@cookmedical.com.
The FDA is encouraging healthcare professionals and patients to reports any related adverse health events or side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.