Intra-Aortic Balloon Pump Catheter Recall Lawsuit

On February 2, 2009, Arrow International issued an urgent nationwide recall regarding certain volume connectors for its 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters.

On April 13, 2009, Teflex Medical and Arrow International in association with the U.S. Food & Drug Administration (FDA) reclassified the Intra Aortic Balloon Pump Catheter recall as a class 1 recall. Class 1 recalls are the most serious type of recall, 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.

If you or a loved one have been injured by the Arrow or Teflex Intra-Aortic Balloon Pump, you should contact us immediately. You may be entitled to compensation for your injuries and we can help.

What’s the problem?

This recall is being conducted because a fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 cc or 5 cc, rather than the appropriate 30, 40, or 50 cc volume. In patients exhibiting moderate to severe myocardial ischemia or low perfusion states, prolonged exposure to the low default volume may fail to decrease ischemia and increase perfusion, leading to organ injury or infarct and may result in patient death. Prolonged exposure to a device which is inflated to less than 2/3 full could also result in thrombus formation on the IAB and possible subsequent systemic or cerebral thromboembolism.

IAB Recall List

At this time, there have been 25 complaints of this issue. There have been no reports of patient injury as a result of this issue. Approx. 423 lots are affected by this recall for a total 45,211 units.

PRODUCTS AFFECTED: 30/40/50 CC IAB Catheters:

PRODUCT CODES: IAB-04830-U, IAB-04840-U, IAB-05830-LWS, IAB05830-U, IAB-05840-U, IAB-05840-LWS, IAB06830-U, IAB06840-U, IAB-S730C, IAB-S840C, IAB-R950-U, IAK-02692, IAK-02693, and IAK-02691.

ADDITIONAL RESOURCES:

• FDA Recall Announcement
• Manufacturers Recall Page (includes recall list and other related materials)

Do I Have an Arrow / Teflex Intra-Aortic Balloon Pump Catheter Recall Lawsuit?

The Medical Device and Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in product liability lawsuits. We are pursuing individual IAB recall litigation nationwide and currently accepting new Intra-Aortic Balloon Pump injury and death cases in all 50 states.

Again, if you or a loved one have been injured by the Arrow or Teflex Intra-Aortic Balloon Pump, you should contact us immediately. You may be entitled to compensation for your injuries and we can help.