Teleflex Medical, Arrow International Inc. 30, 40, and 50 cc Intra-Aortic Balloons
Class 1 Recall
|February 2, 2009|
Arrow International 30, 40, and 50 cc Intra-Aortic Balloons
The recalled models include:
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.
|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.|
|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.|
|The company may be contacted at 1-617-389-6400.|
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:
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.