Z-1218-2009

7 FR 30CC Rediguard IAB, IAB-S730C, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized...

Name: Z-1218-2009 7 FR 30CC Rediguard IAB, IAB-S730C, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized...
Creator: Arrow International, Inc.
Published: 2009-02-02
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2009-02-02 / Terminated / root cause: manufacturing process

FDA source

Arrow International, Inc. began a recall of 7 FR 30CC Rediguard IAB, IAB-S730C, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby... on 2009-02-02. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1218-2009
Status: Terminated
Initiated: 2009-02-02
Posted: 2009-04-16
Terminated: 2010-07-06
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: 7 FR 30CC Rediguard IAB, IAB-S730C, 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.
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 4,411 units
Distribution: Worldwide Distribution: USA, Argentina, Australia, Taiwan, Singapore, New Zealand, India, Brazil, Belgium, Korea, Peru, Finland, and Denmark.
Product codes and lots: Lot/Serial Numbers: MF7012650 MF7065398 MF7076011 MF7086585 MF7086981 MF7097060 MF7097473 MF7107623 MF7117871 MF7128553 MF8018756 MF8018814 MF8019001 MF8019036 MF8029114 MF8029190 MF8039773 MF8039989 MF8040133 MF8050762 MF8050763 MF8050985 MF8051093 MF8061455 MF8071620 MF8082323 MF8082324 MF8082325 MF8092832 MF8103260 MF8124197 MF8124198 MF8124198 and MF8124282.

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)