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7.5 Fr 30cc UltraFlex IAB recallZ-1214-2009 · Arrow International, Inc. · initiated Feb 2, 2009

Terminated All recalls posted in April 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Arrow International, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Process design

What the company is doing

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.

Recall details

Recall number
Z-1214-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 2, 2009
Posted by the FDA
Apr 16, 2009
Recalling firm
Arrow International, Inc.
Quantity
2,691 units
Product code
DSP
FDA submissions
K000729, K010330, K021462, K040801
Distribution
Worldwide Distribution: USA, Argentina, Australia, Taiwan, Singapore, New Zealand, India, Brazil, Belgium, Korea, Peru, Finland, and Denmark.

Product description

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.

Code information (models, lots, serial numbers)

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.

Other devices under the same FDA submission

14 devices cleared under K000729, K010330, K021462, K040801 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 51080).

Sources and updates

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