FDA Alerts – Class I recall of ARROW Endurance Extended Dwell Peripheral Catheter System due to defect

Teleflex and Arrow International have recalled ARROW Endurance Extended Dwell Peripheral Catheter System because the catheter was found prone to separating or leaking, according to the FDA. Due to the significant health risks (“serious injuries or death”) posed by the potential issue, the recall has been labeled Class I, the most serious type.

Indicated for short-term use by healthcare providers to access a patient’s peripheral vascular system, the ARROW Endurance Extended Dwell Peripheral Catheter System facilitates blood sampling, blood pressure monitoring, and the administration of “fluids, blood, and blood products.”

The recall was first initiated by Teleflex, and subsidiary Arrow International, on May 19, 2023, after the firm received reports that detailed catheter separation or leakage. The issue presents serious ramifications; if a catheter were to separate while in a blood vessel, traces of the catheter could be left in the bloodstream, which could then be conveyed to other areas of the body. The recall’s Class I label accounts for the risks of serious injury during use of the product: “blockage of blood vessels, inadequate blood flow, injury to blood vessel walls, blood clots, blockage of the lung arteries (pulmonary embolism), heart attack, or death.”

To date, Teleflex and Arrow International have received 83 complaints, 18 reported injuries, and no reported deaths in connection to the problem.

In a May 19, 2023 Urgent Medical Device Recall letter sent to customers, Teleflex and Arrow International urged readers to be advised that those primarily affected by the recall are patients who receive care through the ARROW Endurance Extended Dwell Peripheral Catheter System. A number of recommended actions were outlined for medical facilities and distributors alike:

Medical Facilities

  • Immediate action items:
    • check inventory for products covered by the recall
    • cease use and distribution of all affected products
    • quarantine affected products
  • Read the acknowledgement form included with the letter and mark the appropriate checkbox (affected product or no affected product). Either fax the form back to 1-855-419-8507 to the Attn: Customer Service, or email the form to recalls@teleflex.com.
    • A customer service representative will reach out to arrange the return of affected products and issue a credit note after the returned item is received.
    • When completing the form, double-check that only recall-covered batch numbers are listed.


  • Immediate action items:
    • Cease use and distribution of products covered by recall
    • quarantine affected products
    • arrange for return of all affected products
  • Disseminate the Urgent Medical Device Recall letter to all impacted customers and ensure that each customer completes and returns the acknowledgement form to the distributor
  • Communicate with Teleflex to confirm all outlined field activities have been completed.
  • After actions are completed, send a completed acknowledgement form to recalls@teleflex.com
    • When completing the form, double-check that only batch numbers covered by the recall are listed
  • Alert Teleflex Customer Service if any affected products were distributed outside of the U.S.

Recall-related questions can be directed to Teleflex and Arrow International Customer Service at 1-866-396-2111, or via email at recalls@teleflex.com.

As the FDA continues to oversee this recall, healthcare providers and consumers are encouraged to report any adverse events to the agency’s MedWatch program.


Have you or a loved one suffered an adverse health outcome that can be traced to the use of a compromised medical device? After a traumatic medical event, your family deserves compassionate legal support and maximum compensation. Our experienced attorneys at TruLaw are personally invested in helping families like yours fight for the best possible outcome. Connect with us online or try out our free Instant Case Evaluation ℠ to learn more.