Imperative Care Catheter Recalled Due to Risk of Breaks During Use
The FDA has issued on update on Imperative Care’s Aug. 18 recall of its Zoom 71 Reperfusion Catheter, deeming it a Class I recall because of the risk of serious injury or death.
The reason for the recall is the risk of breakage of the catheter at the tip during use, which 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,” the FDA said.
The 3,098 affected products were distributed from Sept. 23, 2020, to Aug. 9. 2021. The agency said nine serious injuries, but no deaths, have been reported as a result of the defect.