Percutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Catheters Model: IAK-05845
This recall has been terminated (originally issued December 23, 2010).
- Recall Initiated
- October 11, 2010
- Posted
- December 23, 2010
- Terminated
- February 5, 2015
- Recall Number
- Z-0969-2011
- Quantity
- 714
- Firm Location
- Everett, MA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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 Zealand, Panama, Peru, Philippines, Taiwan, Thailand, and Venezuela.
Lot / Code Info
Lot Numbers: KF0118523 MF8092597 MF8103402 MF8114055 MF9014548 MF9046091 MF9056823 MF9057130 MF9078053 MF9088776 MF9099410 MF9109907
Root Cause
Device Design
Action Taken
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.