February 25, 2022
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Arrow recalls percutaneous thrombolytic device due to risk for tip damage during use
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Arrow International issued a recall of its percutaneous thrombolytic device due to risk for tip damage during use and subsequent detachment from the basket.
According to the FDA press release, basket detachment may cause vascular injuries, vessel obstruction, additional thrombosis, ischemia, MI, infection or death.
This recall encompasses all devices (Arrow-Trerotola) manufactured from 2020 to 2021.
The FDA has identified this as a class I recall, the most serious type of recall, meaning use of these devices may cause serious injuries or death. There have been 35 complaints about this device issue, 14 injuries and no deaths reported, according to the release.
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