Cook Medical initiated a voluntary recall of 4,146,309 catheters with Beacon Tip technology.
Catheters with Beacon Tip technology have been found to exhibit polymer degradation of the catheter tip, resulting in tip fracture and/or separation, which have resulted in 30 Medical Device Reports to date.
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 include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
Cook Medical has notified its customers and distributors by recall notification letters. The letters requested that all customers and distributors quarantine and discontinue use of all potentially affected units and return the affected product to Cook as soon as possible for credit.
Catheters with Beacon Tip technology are intended for use by physicians who are trained and experienced in each of the procedures for which these devices are indicated for use.
This recall includes all lots of catheters with the Beacon® Tip technology. A full product listing is attached. Products can be identified by the part number on the outer package of the product label. Products in this recall were distributed globally.
Cook Medical identified an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.
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 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.