Curon Stretta
This article was originally published in The Gray Sheet
Executive Summary
Voluntary recall of all affected lots of the catheters for treatment of gastroesophageal reflux disease (GERD) is complete, Curon announces Jan. 5. A "manufacturing irregularity" related to 278 catheters "has been identified, and we have resumed normal manufacturing processes," Curon says. The firm does not expect "a major impact" on 2001 fiscal year results, according to President and CEO John Morgan. The device received 510(k) clearance in April (1"The Gray Sheet" Oct. 2, 2000, p. 16)