Dive Brief:
- Cook Medical has recalled nearly 27,000 blood vessel imaging catheters over a fault linked to three serious injuries, the Food and Drug Administration said Wednesday.
- The company withdrew the affected products from the market after learning that the tip may separate from the device. Tip separation could lead to outcomes including sepsis, vessel perforation and death.
- Cook has asked customers with affected Beacon Tip Catheters to quarantine any unused devices and immediately stop all distribution of the products.
Dive Insight:
Cook recalled Beacon devices because of the risk of tip separation in 2015 and 2016.
The company began the latest recall in May after receiving four field complaints about tip separation before and during patient contact. Cook’s investigation found the fault results from process deviation by one specific operator. Applicable parts manufactured by the operator are in scope, according to Cook.
The FDA published a Class I recall notice about the fault. The classification reflects the potential harms a patient could suffer if the tip separated from the device during a procedure.
“If an affected product is used, potential patient harms such as catheter fragmentation and embolization may occur,” the FDA said in its recall notice. “Medical consequences associated with device fragmentation or separation may include sepsis, vessel perforation, thrombosis, embolism, cardiac arrhythmia and death.”
