Cordis Balloon Catheters Recalled for Deflation Problems
January 28th, 2008 amy
Johnson & Johnson’s Cordis Corporation and the FDA have informed healthcare professionals of a worldwide recall of approximately 132,000 balloon catheters used in angioplasty procedures. The product has a potential for slow deflation or no deflation of the angioplasty balloon when inserted into the artery or other blood vessels. This may potentially result in a total blockage of the artery or blood vessels, resulting in a change in the heart rate or heart rhythm, injury to the heart artery, a heart attack, need for a surgical procedure, or death.
This Class I recall applies to All Fire Star and Dura Star balloon catheters, lots 13173912 through 13315455, plus 52 additional lots above 13315455. The recalled catheters were made in Mexico from February to December last year and distributed worldwide from March 26, 2007, to Jan. 8 2008. Approximately 57,000 of the total 132,000 recalled were distributed to the U.S.
