Intra-Aortic Balloon Pump Catheter Recall Arrow International

Arrow IAB Pump Catheter Recall:
Teleflex Medical announced that the U.S. Food and Drug Administration (FDA) has classified the voluntary medical device recall initiated on February 2, 2009 by Arrow International involving volume connectors for its 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters as a Class 1 recall. The FDA defines Class I recalls as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Why The IAB Pump Catheters Have Been Recalled:
Intra Aortic Balloon (IAB) Pump Catheters are being recalled because they may contain defective volume connectors for the 30cc, 40cc, and 50cc sizes. The faulty connectors in the tubing assembly can cause the pumps delivering the medication through the catheters to default to a volume flow of 2.5cc or 5 cc rather than the appropriate 30, 40, or 50 cc volume. According to the FDA, prolonged exposure to the reduced flow of medication can lead to deadly organ failure in patients. According to the recall notice, there have been 25 complaints about the problem associated with the faulty catheter connectors.

What Catheters Have Been Recalled:
The recall involves Intra-Aortic Balloon Pump Catheters in 30, 40, and 50 cc sizes of the following models:

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 recall affects about 45,000 devices sold in 423 lots. These products were manufactured from January, 2008 through January, 2009 and were distributed from January, 2008 through January 23, 2009. For a full list of the recalled lots click here.

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

IAB Pump Catheter News Archive >>>

FDA Recall Notice >>>

If you or a loved one have been injured or suffered a loss due to a defective Intra-Aortic Balloon Pump Catheter you may be entitled to compensation. Conatact the IAB Pump Catheter Attorneys of Ennis & Ennis, P.A. today for a free case evaluation by filling out the online form on this page or call toll free: 1-800-856-6405. Our experienced IAB Pump Catheter Lawyers can answer any questions you may have about the Arrow Catheter Recall and potential IAB Pump Catheter Lawsuit.

Arrow Intra-Aortic Balloon Pump Catheters Recalled:

What Catheters Have Been Recalled: The recall involves Intra-Aortic Balloon Pump Catheters in 30, 40, and 50 cc sizes of the following models:

IAB Pump Catheter News Archive >>> FDA Recall Notice >>>

What Catheters Have Been Recalled:
The recall involves Intra-Aortic Balloon Pump Catheters in 30, 40, and 50 cc sizes of the following models:

IAB Pump Catheter News Archive >>>

FDA Recall Notice >>>