FDA announces recall of more than 3,000 catheters after 9 serious injuries
The FDA has announced that Imperative Care is recalling multiple lots of its Zoom 71 reperfusion catheter, used to remove blood clots in stroke patients, due to a heightened risk that it could break during use.
“This could lead to fractured pieces left inside the patient’s bloodstream, resulting in serious adverse events such as blockage of blood vessels, stroke and death,” according to the FDA’s advisory.
This is a Class I recall, meaning the use of this device “may cause serious injuries or death.” A total of nine serious injuries have been reported so far; there have been no deaths.
The recall includes 3,098 units distributed from September 2020 to August 2021. Imperative Care first alerted its customers back in August, asking them to “remove and quarantine all unused affected products.” These products can then be returned to Imperative Care, and the company pledged to help customers find a suitable replacement.
The full FDA advisory is available here.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.