Applied Medical Python Embolectomy Recall Class 1

FDA says an Applied Medical 10/24/19 recall of Python Embolectomy, BARD Embolecomy, and OTW Latis cleaning catheters due to the risk of separation during use is a Class 1 recall. A notice says 19,400 recalled units were manufactured between 7/23/15 and 11/8/18 and were distributed 8/25/15 to 3/1/19.

The notice says the units were recalled due to a risk of the catheter tip detaching during use. “If the tip detaches, pieces of the catheter could break off into the patient’s body,” the notice says. “If this occurs there is also the potential for serious health consequences including additional surgical procedures to remove the tip, damage to the blood vessels, or death.”

FDA says there have been 46 complaints regarding the issue since 2015. The agency says it has received three medical device reports and no reports of death or injury.