Like the Bard PowerPort and the Penumbra Jet 7 catheters, the ARROW Endurance Extended Dwell Peripheral Catheter System has raised concerns in the medical community. The FDA announced the Arrow catheter recall on June 26, 2023, in light of reports of injuries. Classified as a Class I recall, which is the most serious type, the FDA identified that these devices may result in severe injuries or even fatalities. Therefore, with such a high-stakes recall, healthcare providers and patients must be aware of the potential dangers and take appropriate actions to ensure patient safety.
The ARROW Endurance Extended Dwell Peripheral Catheter System provides healthcare providers access to a patient’s peripheral vascular system for short-term use. For example, these catheters play a vital role in various medical procedures, like sampling blood, monitoring blood pressure, or administering fluids, blood, and blood products. Overall, the system offers a convenient and efficient means of delivering necessary treatments and overseeing patients’ vital signs.
The recall of the ARROW Endurance Extended Dwell Peripheral Catheter System stems from reports of catheter separation or leakage. If the catheter separates while in the blood vessel, fragments could migrate to other parts of the body through the bloodstream. Consequently, this catheter separation can lead to severe complications, including:
Teleflex and its subsidiary Arrow International reported 83 complaints related to this issue, including 18 injuries. While 18 injuries have been documented, no deaths have been reported thus far.
On May 19, 2023, Teleflex and Arrow International sent an Urgent Medical Device Recall letter outlining their recommendations for medical providers and distributors following these injury reports.
The Lake Law Firm will continue to monitor this product and potential injuries that may have been caused as a result of its use.