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8 Fr 40cc Ultra 8 IAB recallZ-1213-2009 · 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-1213-2009
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
10,713 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

8 Fr 40cc Ultra 8 IAB, IAB-05840-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 Number/Serial Numbers: MF7065606 MF7076012 MF7076021 MF7086462 MF7086736 MF7107536 MF7107537 MF7107694 MF7107696 MF7118048 MF7118049 MF7118050 MF7118151 MF7118221 MF7118222 MF7128472 MF7128506 MF7128507 MF8018908 MF8019033 MF8019034 MF8019035 MF8019104 MF8029191 MF8029433 MF8029434 MF8039774 MF8040251 MF8040287 MF8050764 MF8050812 MF8050966 MF8061267 MF8061413 MF8071676 MF8071863 MF8082268 MF8082507 MF8093002 MF8103280 MF8103416 MF8103571 MF8113836 MF8113919 MF8113951 and MF8124345.

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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