June 16, 2024

Teleflex and its subsidiary, Arrow International, have initiated a Class I recall of the ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits. This recall, the most serious type issued by the FDA, addresses critical safety concerns that may lead to serious injuries or death.

Recalled Product Details

  • Product Name: ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits
  • Devices Recalled in the U.S.: 334,995
  • Distribution Dates: December 1, 2021 – January 27, 2024
  • Recall Initiation Date: February 12, 2024

Device Use

These kits are used by healthcare providers to access a patient’s peripheral arterial circulation or other small vessels.

Reason for Recall

The recall follows reports of increased resistance in the guidewire handle and chamber during use, which could lead to severe complications, including:

  • Injury to blood vessel walls
  • Narrowing of the blood vessels (vasospasm)
  • Artery blockage (embolism)
  • Death

So far, there have been 194 complaints, 10 reported injuries, and one reported death related to this issue.

Affected Individuals

Patients receiving care involving the recalled catheterization kits may be at risk.

Recommended Actions for Medical Facilities and Distributors

Medical Facilities:

  • Check and quarantine affected inventory.
  • Stop using and distributing the recalled products.
  • Complete and return the acknowledgment form to Teleflex.
  • Coordinate the return of affected products with customer service.

Distributors:

  • Inform all customers about the recall.
  • Ensure customers complete and return the acknowledgment form.
  • Quarantine and return affected inventory.
  • Confirm completion of field activities to Teleflex.

Contact Information

For questions or more information, contact Teleflex and Arrow International Customer Service at:

This urgent recall is a crucial step to ensure patient safety and prevent further incidents related to these catheterization kits