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7.5 Fr 40cc UltraFlex IAB recallZ-1215-2009 · 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-1215-2009
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
7,325 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 40cc UltraFlex IAB, IAB-06840-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:  MF8029428 MF8029506 MF8029508 MF8030125 MF8030126 MF8039646 MF8039647 MF8039762 MF8039851 MF8040487 MF8040640 MF8050724 MF8061127 MF8061503 MF8071787 MF8072071 MF8082286 MF8082508 MF8093047 MF8103162 MF8103418 MF8103642 MF8113920 MF8114010 MF8124162 and MF8124162.

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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