Yesterday FDA released information about a voluntary recall of Cook Medical’s catheters with Beacon Tip technology. On April 15, the company recalled 4,146,309 catheters that were found to exhibit degradation of the catheter tip, which results in tip fraction and/or separation. This problem has resulted in 30 Medical Device Reports (MDR) thus far.
Catheter polymer degradation can cause adverse events such as loss of device function, separation of a device segment (which can necessitate medical intervention), and other complications from a separated segment, including device fragments in the vascular system (which can lead to heart or lung embolization or blood flow occlusion to organs), genitourinary system and other soft tissues.
According to the FDA safety alert, Cook Medical found an increase in reports related to the polymer degradation. Upon preliminary investigation, the company identified environmental conditions, including storage temperature, humidity and vaporized hydrogen peroxide (used to decontaminate rooms in healthcare facilities) as potential contributing factors. Cook Medical continues to investigate the matter.
The recall affects many product families and are listed on Cook Medical’s website.