Recall Z-0792-2011 ยท DSP System, Balloon, Intra-Aortic And Control
Arrow International, Inc., Division of Teleflex Medical Inc.
FiberOptix IAB Sheath, Ultra 8 Fr, 30cc. Model: IAB-05830-LWS
| Date | Dec 23, 2010 (initiated Oct 11, 2010) |
| Status | Terminated |
| Reason | SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury. |
| Root cause | Device Design |
| Action | Arrow international initiated a voluntary recall on 12/21/10 by letter requesting users to discontinue use and return all unused 5800 Series IAB with SuperFlex Introducers to Arrow. This field action supercedes the Safety Alert IAB 'Stuck in Sheath' letter issued on 10/8/2010. Questions should be directed towards their local sales representative or the IABP support Line at 1-866-396-2111 or 1-617-389-6400. |
| Quantity | 12, 261 units |
| Distribution | Worldwide Distribution -- USA, Canada, Australia, Belgium, Czechoslovakia, Germany, Russia, Spain, Finland, France, Great Britain, Hungary, Italy, Netherlands, Poland, Saudi Arabia, Switzerland, Brazil, Australia, Chile, Colombia, Ecuador, India, Indonesia, Japan, Korea, Malaysia, Mexico, New Zeal |
| FDA record | Open on fda.gov |