Ra Medical Pulls Dabra Laser Catheters for Relabeling
Ra Medical initiated a voluntary recall of its Debra laser system single-use catheters due to their failure to calibrate before procedures, according to an SEC filing.
Following internal testing, the company said that “while catheters can perform satisfactorily up to one year, catheters that were more than two months from sterilization had a significantly higher rate of non-calibration.”
The company is now relabeling the recalled devices with two-month expiration dates, replacing the previous 12-month shelf life. Ra said the new expiration dates should reduce the number of device calibration failures.