Teleflex recalled the devices over the potential presence of excess material at the distal tip of the catheter. The excess material could separate from the catheter during use, thereby putting patients at risk for an embolism.
The FDA classified the event as a Class 1 recall, meaning it’s a situation “in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death,” according to the company announcement.
The international recall affects 4,679 units in the U.S. No serious adverse events or deaths have been reported in association with the recalled products.
To read the full company announcement, click here.
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