FDA Announces Arrow Catheter Recall

FDA Announces Arrow Catheter Recall

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. 

About the ARROW Endurance Extended Dwell Peripheral Catheter System 

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.  

Reasons for Arrow Catheter Recall 

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:  

  • Blockage of blood vessels 
  • Inadequate blood flow 
  • Formation of blood clots, 
  • Pulmonary embolism 
  • Heart attacks 
  • Death 

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.  

Next Steps After Arrow Catheter Recall  

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. 

Recommended Actions for Medical Facilities:  

  • Check inventory for affected Arrow catheters.  
  • Discontinue the use and distribution of the Arrow catheter immediately. 
  • Quarantine the affected products to prevent unintended use. 
  • Complete the provided acknowledgment form in the letter and return it to Teleflex. 
  • Contact customer service to obtain a Return Goods Authorization (RGA) number and receive instructions on returning the Arrow catheters.  

Recommended Actions for Distributors:  

  • Share the Urgent Medical Device Recall letter with customers who have received the Arrow catheter.  
  • Collect completed forms from customers to ensure their understanding and compliance. 
  • Halt the use, distribution, and quarantine of the Arrow catheter.  
  • Confirm completion of field activities to Teleflex. 
  • Communicate any international distribution of the product to Teleflex Customer Service. 

The Lake Law Firm will continue to monitor this product and potential injuries that may have been caused as a result of its use.