Arrow recalling intra-aortic balloons
Device Regulation Alert: Safety, Compliance and Reimbursement News, April 27, 2009
Arrow International recalled 45,211 units of volume connectors for its 30-, 40- and 50-cc intra-aortic balloon pump catheters manufactured from January 2008 through January 2009 because of faulty connection tubes.
The FDA classified the recall as a Class I recall, the most serious type of recall, in which there is a reasonable probability that use of these products will cause serious injury or death.
Read more about Arrow’s Class I recall.
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