According to recent news reports Arrow International is recalling all 5800 series intra-aortic balloon catheters with the super arrow-flex sheath introducer. The worldwide voluntary recall is a result of increased reports of stuck in sheath incidents where a user is not able to move an IAB catheter backward or forward which may cause a delay in critical therapy. Excessive IAB movement with this device if it becomes stuck in sheath during insertion could result in:
- excessive bleeding
- arterial damage
- significant vasospasm
- prolonged tissue ischemia
- tissue or vascular ischemia
- infarct
- injury
- death
The U.S. Food and Drug Administration has listed this recall as a Class I recall meaning that the use of such a product could result in severe injury or death.
Affected 5800 series IABs have the following product codes and were shipped between Jan. 1 2009 and Dec. 17 2010:
- IAB-05830-U
- IAB-05840-U
- IAB-05830-LWS
- IAB-05840-LWS
- IAK-05845
Details about the recall can be found on the Arrow International IAB recall website.
Product defects in medical equipment can cause severe personal injury or death as attested to by the problems that ultimately led to this recall. It is my hope that this recall is known about so that those possibly affected by the recall can seek appropriate help and so that medical establishments will discontinue using such a defective device. – Texas Product Liability Attorney Michael Grossman
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