—#78455

Product

8 Fr 40cc Narrow Flex IAB Catheter Kit with Generic Adapters Product Number: IAB-04840-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.

FDA product code: DSP — System, Balloon, Intra-Aortic And Control
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K000729, K010330, K021462, K040801
Affected lot / code info: Lot/ASerial Numbers: MF6090318 MF6111511 MF7065955 MF7076255 MF7086556 MF7097114 MF7097115 MF7097226 MF7097227 MF7097228 MF7097427 MF7097470 MF7097471 MF7107861 MF7107862 MF7118045 MF7118046 MF7128470 MF7128508 MF8018724 MF8018813 MF8018996 MF8124303 MF8124304 MF8124304 MF9014426 MF9014444 MF9014446 and MF9014447.

Why it was recalled

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 (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Arrow International, Inc.
Address: 9 Plymouth St, Everett, Massachusetts 02149-1814

Distribution

Distribution pattern: Worldwide Distribution: USA, Argentina, Australia, Taiwan, Singapore, New Zealand, India, Brazil, Belgium, Korea, Peru, Finland, and Denmark.

Timeline

Recall initiated: 2009-02-02
Posted by FDA: 2009-04-16
Terminated: 2010-07-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #78455. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.