www.fdanews.com/articles/68828-guidant-recalls-some-voyager-catheters
Guidant Recalls Some Voyager Catheters
February 16, 2005
Guidant has initiated a recall of its Voyager Coronary Dilatation Catheters sized 1.5 mm to 3.5 mm because of potential leaks.
According to the company's annual report submitted to the SEC, the withdrawal of the catheters was voluntary, but the company has contacted the FDA and affected international regulatory agencies.
"While the probability of a leak is low, the company is pursuing root-cause analysis and corrective actions," Guidant said in its filing. The FDA approved the catheters during the second quarter of 2004, and the product was launched during the third quarter, the filing said.