Applied Medical: Embolectomy and cleaning catheters
The recall involved 19,400 devices, which are latex balloon catheters used for temporary blockage, closing of a blood vessel or infusion of fluids. The devices in the recall have a risk of the catheter tip detaching during use. If the tip detaches, pieces of the catheter could break off into a patient’s body, leading to 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 filed regarding the device since 2015. The FDA has received three medical device reports and no reports of death or injury, according to a May 12, 2020 FDA warning letter.
Applied Medical told healthcare providers to return the devices as part of the recall.
Catheters involved in the recall were made between July 23, 2015, and Nov. 8, 2018, and were distributed between Aug. 25, 2015, and Mar. 1, 2019.
“Applied Medical submitted an FDA termination request for the catheter recall on November 20, 2020. The company received confirmation of receipt from the FDA on Dec. 7, 2020. Applied Medical is currently awaiting the FDA’s official termination of the recall,” an Applied Medical spokesperson told MT+E in an email. “Since the initial recall notification, no injuries have been reported.”
