Peripheral catheter system recalled due to potential for separation, leakage
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The FDA has designated a recall of a peripheral catheter system as class I, the most serious kind.
Teleflex and its subsidiary Arrow International recalled the system (Arrow Endurance Extended Dwell Peripheral Catheter System), which provides access to the peripheral vascular system to sample blood, monitor BP or administer fluids, blood and blood products, due to reports of catheter separation or leakage, according to an alert from the FDA.
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The FDA classified the recall as class I, meaning the problem could lead to serious injury or death.
If the catheter separates while in a blood vessel, fragments could migrate to elsewhere in the body, leading to outcomes including blood clots, pulmonary embolism, MI or death, the agency stated in the alert.
The recall applies to devices distributed from Oct. 26, 2018, to May 10, 2023, and came after 83 complaints linked to 18 serious injuries but no deaths were received, according to the alert.
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