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Recall of Arrow International Intra-Aortic Balloon Catheters

By Burg Simpson
March 18, 2016
2 min read

Medical Device Safety and Recalls: Arrow International Inc. Recalls Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits Due to Sheath Separation Issue

On March 17, 2016 the U.S. Food and Drug Administration (FDA) identified a Class I recall of Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits. These balloon catheters are implanted into patients’ hearts to provide mechanical support for the circulatory system. To implant the device a Teflon cover (sheath) is first inserted into the femoral artery, which allows the device to be passed into the aorta. After insertion the device works to increase cardiac output and reduce stress on the heart by inflating and deflating when necessary.

Class I recalls are the most serious type of recall, issued only when the FDA finds a reasonable probability that use of the product will cause serious adverse health consequences or death. The FDA issued this Class I recall after it received several reports of serious adverse health consequences related to the failure of the Teflon sheath during the insertion process. This failure may cause significant bleeding and interruption of the intended therapy.

The recalled devices were distributed between January 1, 2014 and February 1, 2016 and include the following models:

  • FiberOptix Ultra 8 IAB: 8Fr 30cc – K021462;
  • Ultra 8 IAB: 8Fr 30cc – K000729;
  • FiberOptix Ultra 8 IAB: 8Fr 40cc – K021462;
  • Ultra 8 IAB: 8Fr 40cc – K000729;
  • UltraFlex IAB: 7.5Fr 30cc – K000729;
  • UltraFlex IAB: 7.5Fr 35cc – K000729;
  • UltraFlex IAB: 7.5Fr 40cc – K000729;
  • RediGuard IAB: 7Fr 30cc – K981660;
  • Percutaneous Insertion Tray – K000729;
  • Percutaneous Insertion Tray – K981660

If you or a loved one suffered injuries that you believe were caused by one of the above Arrow International Intra-Aortic Balloon Catheter Kits or Percutaneous Insertion Kits contact one of the experienced medical device attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today

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