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FDA > CDRH > Medical Device Recalls > Class 1 Recall: Teleflex Medical, Arrow International Inc. 30, 40, and 50 cc Intra-Aortic Balloons

Class 1 Recall: Teleflex Medical, Arrow International Inc. 30, 40, and 50 cc Intra-Aortic Balloons

Date Recall
Initiated:
 February 2, 2009
Product:

Arrow International 30, 40, and 50 cc Intra-Aortic Balloons

The recalled models include:

  • 8 Fr 30cc Narrow Flex IAB Catheter Kit, Product Number: IAB-04830-U
  • 8 Fr 40cc Narrow Flex IAB Catheter Kit, Product Number: IAB-04840-U
  • 8 Fr 30cc Ultra 8 IAB, Product Number: IAB-05830-U
  • 8 Fr 40cc Ultra 9 IAB, Product Number: IAB-05840-U
  • 7.5 Fr 30cc UltraFlex IAB, Product Number: IAB-06830-U
  • 7.5 Fr 40cc UltraFlex IAB, Product Number: IAB-06840-U
  • 8 Fr 30cc FIBEROPTIX IAB, Product Number: IAB-05830-LWS
  • 8 Fr 40cc FIBEROPTIX IAB, Product Number: IAB-05840-LWS
  • 7 Fr 30cc Rediguard IAB, Product Number: IAB-S730C
  • 8 Fr 40cc Rediguard IAB, Product Number: IAB-S840C
  • 9 Fr 50cc Rediguard IAB, Product Number: IAB-R950-U
  • ARROW 40cc Drive Line Kits, Product Number: IAK-02692
  • ARROW 50cc Drive Line Kits, Product Number: IAK-02693

The affected lot numbers can be found at: http://www.arrowintl.com/documents/pdf/IAB%20Recall%20APPENDIX%20A%20-%20Affected%20IAB%20Lot%20Numbers.pdf

These products were manufactured from January, 2008 through January, 2009 and were distributed from January, 2008 through January 23, 2009.
Use:
 Intra-Aortic Balloons are a component of the Intra-Aortic Pump System which is designed to provide cardiac assist therapy to critically ill people to increase blood flow to the heart.
Recalling Firm:
 Arrow International, Inc.
9 Plymouth St.
Everett, Massachusetts 02149-1814
Reason for Recall:

The faulty connector of the pump tubing assembly may result in the volume setting on the pump to default to 2.5 ccs or 5 ccs (depending on the Intra-Aortic Balloon Pump model) rather than the appropriate 30, 40, or 50 cc volume.

Public Contact:

The company may be contacted at 1-617-389-6400.

FDA District:
 New England
FDA Comments:

On February 6, 2009, the company sent their distributors and customers a recall letter by certified mail to inform users about the problem. Users were:

  • instructed to return the recalled products
  • provided directions to continue using the product with specific instructions

For more information about this recall, please see the company’s recall letter at: http://www.arrowintl.com/documents/pdf/IAB%20Medical%20Device%20Recall%20Notification.pdf

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Updated April 15, 2009

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