Applied Medical is recalling their Python Embolectomy Catheters, Bard Embolectomy Catheters and OTW Latis Cleaning Catheters because there is a risk of the catheter tip detaching during use. The US Food and Drug Administration (FDA) has identified this as a Class I recall as use of these devices may cause serious injuries or death.
If the tip detaches, pieces of the catheter could break off into the patient’s body. If this occurs, there is also the potential for serious health consequences including additional surgical procedures to remove the tip, damage to the blood vessel or death.
There have been 46 complaints regarding this device issue since 2015. The FDA has received three medical device reports (MDRs) and no reports of death or injury.
Recalled Product: Python Embolectomy Catheters, Bard Embolectomy Catheters and the OTW Latis Cleaning Catheters
· Model Numbers: Python Embolectomy Catheters: A4E01, A4E02, A4E03, A4E04, A4E05, A4E06, A4E08, A4E09; Bard Embolectomy Catheters: CE0340DR, CE0380DR, CE0440DR, CE0480DR CE0540DR, CE0580DR, CE0680DR; OTW Latis Cleaning Catheters: A4GW6
· Manufacturing Dates: July 23, 2015 to November 8, 2018
· Distribution Dates: August 25, 2015 to March 1, 2019
· Devices Recalled in the U.S.: 19,400
The Python Embolectomy Catheters, Bard Embolectomy Catheters and OTW Latis Cleaning Catheters are latex balloon catheters used for temporary blockage, closing of a blood vessel or infusion of fluids.
