Imperative Care Zoom Catheter Recall is Class 1

FDA says the Imperative Care 8/18 recall of specific lots of its ZOOM 71 reperfusion catheter due to the risk of breaks during use is Class 1. The company recalled 3,098 devices distributed in the U.S. between 9/23/20 and 8/9/21.

Imperative Care says the ZOOM 71 catheter is used with the ZOOM aspiration tubing and ZOOM aspiration pump or an equivalent vacuum pump to remove blood clots in the brain of a patient within eight hours of an acute ischemic stroke caused by blocked or narrowed arteries.

The company says it initiated the recall due to an increased risk of the catheter breaking at the distal tip during use, such as when it is retracted forcefully. “If the device breaks during use,” it says, “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.”

FDA says there have been nine reports of serious injuries and no reports of deaths.