Z-0791-2011

Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U

Name: Z-0791-2011 Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U
Creator: Arrow International, Inc., Division of Teleflex Medical Inc.
Published: 2010-10-11
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2010-10-11 / Terminated / root cause: design

FDA source

Arrow International, Inc., Division of Teleflex Medical Inc. began a recall of Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U on 2010-10-11. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0791-2011
Status: Terminated
Initiated: 2010-10-11
Posted: 2010-12-23
Terminated: 2015-02-05
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U
Product code: DSP System, Balloon, Intra-Aortic And Control
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.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: 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

Product code DSP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)