The Food and Drug Administration (FDA) on October 6 identified the recall by Imperative Care Inc of its ZOOM 71 Reperfusion Catheter as Class I, the most serious.
The ZOOM 71 Reperfusion Catheter is used to remove blood clots from a patient’s brain within 8 hours of an acute ischemic stroke.
The recall was initiated because of an increased risk of the catheter breaking at the distal tip during use, such as when it is retracted forcefully.
Distribution dates were September 23, 2020, to August 9, 2021.
There have been nine reports of serious injuries and no deaths.
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