FDA Medical Device Recalls (openFDA)
Arrow International, Inc.: 7.5 Fr 30cc UltraFlex IAB, IAB-06830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.
- Recall number
- Z-1214-2009
- Recalling firm
- Arrow International, Inc.
- Product
- 7.5 Fr 30cc UltraFlex IAB, IAB-06830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.
- Status
- Terminated
- Initiated
- 2009-02-02
- Posted
- 2009-04-16
- Terminated
- 2010-07-06
- Reason
- A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume.
- Root cause
- Process design
- Action
- An "Urgent Medical Device Recall" letter dated February 2, 2009 was issued to consignees via US Certified Mail to notify users of the problem. Users were instructed to check their inventory for the affected products, quarantine, and return the them to Arrow International, Inc. Customers were also instructed to follow the "Mitigation Directions" in circumstances where alternate Intra-Aortic Balloon (IAB) catheters/adaptors or other forms of therapy are not available (until receipt of available product). Canadian accounts were notified on February 9, 2009 by courier and International accounts notified on 6 February 2009 and 10 February 2009 via Registered Post/UPS. Direct questions to your local Sales Representative or the Arrow International Customer Service at 1-800-523-8446 (US) or 1-919-361-4062 (outside US). Press Release issued April 13, 2009 is posted to firm's webiste: http://www.arrowintl.com/iab_recall.asp.
- Quantity
- 2,691 units
- Distribution
- Worldwide Distribution: USA, Argentina, Australia, Taiwan, Singapore, New Zealand, India, Brazil, Belgium, Korea, Peru, Finland, and Denmark.
- Lot, serial or model codes
- Lot/Serial Numbers: MF8039760 MF8039772 MF8040252 MF8040485 MF8040486 MF8040639 MF8050723 MF8050807 MF8050914 MF8061336 MF8061458 MF8061616 MF8061617 MF8071677 MF8071855 MF8082154 MF8082586 MF8092763 MF8093004 MF8103159 MF8103160 MF8103264 MF8103265 MF8103417 MF8124181 MF8124203 MF8124413 and MF8124414.
- 510(k) numbers
- K000729, K010330, K021462, K040801
- 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
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
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 3e6df46828c1, published 2026-10-06