8 Fr 40cc Narrow Flex IAB Catheter Kit with Generic Adapters Product Number: IAB-04840-U, Intra-aortic balloon catheter.

FDA device recall Z-1211-2009 · posted 2009-04-16 · Terminated

Recall details

Recalling firm

Arrow International, Inc.

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.

Action taken

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.

Root cause

Process design

Status

Terminated

Product code

DSP

Quantity affected

5,332 units

Distribution

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

Date initiated

2009-02-02

Date posted

2009-04-16

Date terminated

2010-07-06

Location

Everett, MA

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