FDA Medical Device Recalls (openFDA)
Arrow International, Inc., Division of Teleflex Medical Inc.: Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U
- Recall number
- Z-0791-2011
- Recalling firm
- Arrow International, Inc., Division of Teleflex Medical Inc.
- Product
- Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U
- Status
- Terminated
- Initiated
- 2010-10-11
- Posted
- 2010-12-23
- Terminated
- 2015-02-05
- 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
- 13, 391 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 Zealand, Panama, Peru, Philippines, Taiwan, Thailand, and Venezuela.
- Lot, serial or model codes
- Lot Numbers: KF0087855 KF0087856 KF0098040 KF0108374 MF0011189 MF0021654 MF0032271 MF0042406 MF0042501 MF0042786 MF0053023 MF0063353 MF0073903 MF0074071 MF7065606 MF7086741 MF7118151 MF7128507 MF8103280 MF8103571 MF8113919 MF8113951 MF8124345 MF9014575 MF9014817 MF9024965 MF9024993 MF9025112 MF9025209 MF9035509 MF9035685 MF9035955 MF9046057 MF9046247 MF9046501 MF9056746 MF9057069 MF9057070 MF9067275 MF9067738 MF9067740 MF9077954 MF9078048 MF9078052 MF9078348 MF9078349 MF9088685 MF9100025 MS0053114 MS9056684 MS9056857 MS9057154 MS9110263 MS9110269
- 510(k) numbers
- ["K000729","K021462"]
- PMA numbers
- not on file
- Product code
- DSP
- Firm FEI
- 3010532612
- Firm city
- Everett
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28