The FDA announced today 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.
All three types of affected catheters are latex balloon catheters used for temporary blockage, closing of a blood vessel or infusion of fluids.
Applied Medical recalled the catheters because there is a risk of the catheter tip detaching during use, which could cause pieces of the device to break off into the patient’s body. If this occurs, there is the potential for additional surgical procedures, damage to the blood vessel or death.
Since 2015, there have been 45 total complaints regarding the detaching tip issue with these specific catheters. The FDA received three medical device reports with no report of injury or death. Users are urged to return affected devices to Applied Medical.