Medtronic’s HawkOne Directional Atherectomy System received a a Class I recall from the U.S. FDA, the most serious type of recall which may lead to serious injuries or death.
In its recall letter, Medtronic reiterated the “existing warnings and precautions” in the HawkOne system’s instructions for use regarding risk with catheter tip damage caused by guidewires moving, according to FDA.
“The consignees are informed that no updates will be applied to the current HawkOne [instructions for use] at this time and patients should continue to be monitored per the practice’s normal follow-up procedures,” according to the agency’s recall database. “There are no actions required for patients where HawkOne was previously used during a procedure and there are no product retrievals or disposals requested by Medtronic.”
FDA stated in its Friday notice that Medtronic told customers to share the recall information with people in the organization and any organization where products were transferred, to check the system before use and complete a “customer confirmation form” that was enclosed in the recall letter.
Read the full story at Med Tech Dive.