FDA Issues Warning on Catheters
On June 26, 2023, the U.S. Food and Drug Administration (FDA) identified a product recall by Teleflex and its subsidiary, Arrow International, for their product the ARROW Endurance Extended Dwell Peripheral Catheter System. The recall was first initiated by the firm on May 19, 2023, because of the risk of catheter separation and leakage. The FDA has identified this case as a Class I recall, which is the most serious kind. In some instances, they have implied that the use of these devices may cause serious injuries or death.
The recall affects a large sum of 262,016 devices that were distributed in the U.S. from October 26, 2018, to May 10, 2023. The firm has reported a total of 83 complaints related to the issue, with 18 reported injuries and no deaths at this time. If you were affected by a recall, make sure to contact a defective medical devices attorney in Chicago today.
The Reason Behind the Recall
Arrow International and its parent company Teflex initiated the recall of the ARROW Endurance Extended Dwell Peripheral Catheter System due to reports of separation or leakage with the catheters. If these catheters separate while in venous or arterial use, the fragments could end up in the patient’s bloodstream and migrate to other regions of the body.
This can lead to serious injuries, such as blood vessel blockages, blood flow issues, injuries to the blood vessel walls, blood clots, lung artery blockages (also known as pulmonary embolism), heart attacks, or even death.
ARROW International has received approximately 83 complaints related to these findings. 18 injuries have been reported, but no deaths at this time.
The individuals most at risk are those who have received care with the ARROW Endurance Extended Dwell Peripheral Catheter System. The device gives health practitioners access to a patient’s peripheral vascular system. They can then facilitate the collection of sample blood and blood pressure monitoring, as well as the administration of fluids, blood, and blood products.
What Guidelines Have Been Given?
All patients who have received treatments utilizing the ARROW Endurance Extended Dwell Peripheral Catheter System should reach out to their healthcare providers.
As for Medical facilities and Distributors, on May 19, 2023, Teleflex sent out an urgent recall letter to all customers giving detailed information on what to do with their devices and how to go forward.
Medical facilities are advised to:
- Verify inventory for any products included in the recall.
- Cease using and distributing the affected product immediately.
- Isolate the affected product in a designated quarantine area.
- Complete the acknowledgment form provided with the letter by checking the appropriate checkbox (affected product or not affected product). Fax the form to 1-855-419-8507, Attn: Customer Service, or email it to [email protected].
- If you possess the affected product, a customer service agent will reach out to you to provide a Return Goods Authorization (RGA) number and instructions for returning the product to Teleflex. Once the returned affected product is received, Teleflex (or the local dealer) will issue a credit note.
- When filling out the form, ensure that you only list batch numbers within the scope of the recall notice.
Distributors are advised to:
- Distribute copies of the Urgent Medical Device Recall letter to all customers who have received the affected product. Each customer must fill out and return the acknowledgment form to the distributor.
- Cease the use and distribution of the affected product immediately and place it in quarantine. Arrange for the return of all products within the scope of the recall.
- Notify Teleflex once the required field activities outlined in the recall have been completed.
- After completing the necessary actions, submit the completed acknowledgment form to [email protected].
- When filling out the form, ensure that you only include batch numbers specified in the recall notice.
- If the product is distributed internationally, inform Teleflex Customer Service accordingly.
Summary
This catheter system has demonstrated issues that must be taken seriously. All usage of the ARROW Endurance Extended Dwell Peripheral Catheter System must cease immediately. Customers can reach out to Teflex for more information. 
How Can Meyers & Flowers Help?
The Meyers & Flowers team is dedicated to protecting the rights of those injured by defective and dangerous medical devices. If you or a family member have been injured by the ARROW Endurance Extended Dwell Peripheral Catheter System, we encourage you to contact us to explore your legal options. Our team of Chicago personal injury attorneys is here for you.