Ra Medical Systems Inc. is voluntarily recalling its Dabra laser system single-use catheters to update the product labeling after performance issues were discovered.
The Carlsbad, Calif.-based medical-device company's Dabra laser system is used to treat blockages in arteries via laser radiation.
The company issued the recall as the catheters were experiencing performance inconsistencies and failing to calibrate before a procedure. Field data and internal testing showed that while the catheters could be used for up to a year, versions older than two months past sterilization had a greater probability of noncalibration issues.
Ra Medical is relabeling the catheters with a two-month expiration, replacing the previous one-year expiration date. The company will recall the catheters at customer sites and replace them with products featuring the new labels. Costs incurred due to the recall are estimated to be between $200,000 and $400,000.
