Outback Catheter

• • Terminated Z-0279-2009 FDA Unclassified (pre-2012) ·initiated 20 Aug 2008 ·on shared 510(k) K032298

  The Cordis LuMend Outback LTD Re-Entry Catheter - separation rate of the cannula to the deployment slide of the handle assembly is higher than anticipated. The cannula is unable to be retracted into the device after deployment due to a separation of the inner key from the cannula.

• • Terminated Z-0995-04 FDA Unclassified (pre-2012) ·initiated 18 May 2004

  Recall initiated after Lumend received a report of a malfunction of an Outback Catheter in Ohio.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Full name

Modification to Outback Catheter

510(k) Number

K032298 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modification to Outback Catheter

  Class II

  FDA 510(k) K040771 Active Cleared 23 Apr 2004

• Modification to Lumend Frontrunner Cto Catheter

  Class II

  FDA 510(k) K023223 Active Cleared 24 Oct 2002

• Lumend Frontrunner Cto Coronary Catheter

  Class II

  FDA 510(k) K013284 Active Cleared 11 Feb 2002

• Lumend Percutaneous Catheter

  Class II

  FDA 510(k) K011562 Active Cleared 16 Jan 2002

• Outback Catheter

  Class II

  FDA 510(k) K001577 Active Cleared 11 Jan 2001

• Lumend Frontrunner Cto Catheter

  Class II

  FDA 510(k) K023114 Active Cleared 23 Jan 2003

See all devices from Lumend, Inc. →

• Is the Outback Catheter designed for single-use or can it be reused in multiple procedures?

  The Outback Catheter is explicitly supplied as a reusable medical instrument. Since it is intended for repeated use in cardiovascular procedures under fluoroscopic guidance, it must be properly cleaned, disinfected, and maintained between procedures to ensure safety and performance. Reusability is a key feature to support cost-effective procedural workflows.

• What materials are used in the shaft and guide of the Outback Catheter, and how does this affect its performance?

  The Outback Catheter features a 6 Fr. steel-braided polyimide and polyurethane shaft, combined with a single-lumen steel-braided polyimide guide. The steel braiding provides structural rigidity and pushability, while the polyimide and polyurethane materials enhance flexibility and durability. This design enables precise navigation and steerability within peripheral blood vessels, making it ideal for fluoroscopically guided procedures.

• What visual features help clinicians orient and position the catheter during fluoroscopic imaging?

  The Outback Catheter includes a radiopaque multi-beveled guide tip and an index mark on the shaft, both of which improve visibility under fluoroscopy. The radiopaque tip ensures clear imaging contrast, while the index mark provides a reference point for accurate catheter positioning and alignment within the vessel during procedures.

• What type of procedures is this catheter intended for, and why is fluoroscopic visualization required?

  The Outback Catheter is designed for cardiovascular procedures requiring precise vascular access and positioning, such as peripheral angiography or interventional radiology. Fluoroscopic visualization is required because the catheter’s steerable design and radiopaque tip rely on real-time imaging to guide accurate navigation through blood vessels, ensuring safe and effective deployment.