FDA Medical Device Recalls (openFDA)
Arrow International, Inc., Division of Teleflex Medical Inc.: Percutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Catheters Model: IAK-05845
- Recall number
- Z-0969-2011
- Recalling firm
- Arrow International, Inc., Division of Teleflex Medical Inc.
- Product
- Percutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Catheters Model: IAK-05845
- 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
- 714
- 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: KF0118523 MF8092597 MF8103402 MF8114055 MF9014548 MF9046091 MF9056823 MF9057130 MF9078053 MF9088776 MF9099410 MF9109907
- 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