The FDA announced yesterday that the Applied Medical recall of multiple kinds of its catheters is designated as Class I, the most serious type of recall.
The Python embolectomy catheters, Bard embolectomy catheters and the OTW Latis cleaning catheters were the types recalled by Applied Medical. A total of 19,400 devices were recalled in the U.S., having been manufactured between July 23, 2015, and Nov. 8, 2018, and distributed between Aug. 25, 2015, and March 1, 2019. The company initiated the recall on Oct. 24, 2019, according to an FDA release.