Skip to content

8 FR 40CC Rediguard IAB recallZ-1219-2009 · 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-1219-2009
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
15, 012 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 Rediguard IAB, IAB-S840C, 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)

Show the full code information (1k characters)

Lot/Serial Numbers:  MF6090326 MF6101289 MF7012817 MF7065399 MF7065882 MF7076380 MF7086744 MF7097061 MF7097113 MF7097319 MF7097474 MF7118038 MF7118039 MF7128469 MF7128554 MF7128555 MF7128556 MF8018842 MF8018976 MF8019000 MF8019100 MF8029244 MF8029295 MF8029296 MF8029509 MF8039793 MF8039794 MF8039988 MF8040431 MF8040432 MF8040433 MF8040445 MF8040601 MF8040602 MF8040603 MF8050760 MF8050761 MF8050986 MF8050987 MF8050988 MF8051091 MF8051092 MF8061324 MF8061325 MF8061456 MF8071619 MF8071627 MF8071628 MF8071789 MF8071849 MF8072043 MF8082319 MF8082320 MF8082321 MF8082322 MF8092737 MF8092833 MF8092870 MF8092871 MF8092872 MF8092873 MF8103163 MF8103164 MF8103165 MF8103166 MF8103167 MF8103168 MF8103568 MF8103569 and MF8103165.

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

How recalls are matched to devices · Editorial policy · Report an error on this page