The Dabra laser system has experienced inconsistent performance because of catheters that fail to calibrate before procedures, which can result in a temporary delay, according to an SEC filing.
Ra Medical’s review of the production process showed that, while the catheters produced satisfactory results for up to one year, devices used more than two months after sterilization had a significantly higher rate of non-calibration than catheters that were within two months of sterilization, the company said in the filing.
Ra Medical will recall the catheters at customer sites and replace them with relabeled catheters, changing the devices’ previous 12-month shelf life to a two-month expiration. The Carlsbad, Calif.-based company estimates the costs associated with the recall to total between $200,000 and $400,000.
“Ra Medical believes that this change in product labeling will significantly reduce the number of catheters that fail to calibrate and thereby improve customer satisfaction with the product,” the company said in the filing.
Ra Medical is also reviewing and looking to upgrade its manufacturing process to extend the shelf life beyond two months.
The Dabra system is designed to destroy arteriosclerotic blockages through the use of radiation ablation. The system won FDA 510(k) clearance in May 2017 for the treatment after the artherectomy catheter system received CE Mark approval in October 2016.
In June, Ra Medical launched a 2,500-patient large registry study to follow patients treated with Dabra for restenosis in the peripheral arteries.
Shares of RMED were down -11.4% at $1.40 per share in early-morning trading today.