Terumo Recalls, Discontinues Coronary Ostia Cannula Line
The FDA said Terumo decided to remove the product line from the market and discontinue further supply.
The recall involved 6,220 devices, with model numbers 804115, 804117, 804159, all lot/serial numbers. The Terumo Coronary Ostia Cannula is indicated for use in delivering cardioplegia solution directly to the coronary arteries during cardiopulmonary bypass.
The company notified customers by letter describing the problem and the potential hazard.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
For more information: www.fda.gov/Safety/MedWatch/default.htm