FDA designates recall of three latex balloon catheters as class 1
The FDA has designated Applied Medical’s recall of three latex balloon catheters as a class 1 recall, the most serious kind.
The recall affects 19,400 catheters (Python embolectomy catheters, Bard embolectomy catheters, OTW Latis cleaning catheters) manufactured and distributed in the United States between July 23, 2015, and March 1, 2019, according to a safety alert from the agency.
The catheters, which are used to close blood vessels, to clear temporary blockages and to infuse fluids, were originally recalled due to the tip potentially becoming detached during use. Detachment may lead to pieces of the catheter breaking into the patient’s body, in addition to other serious health consequences such as blood vessel damage, additional surgical procedures to remove pieces or death, according to the agency.
Since 2015, there have been 46 complaints associated with this issue. Three medical device reports have been received by the FDA, with no reports of injury of death, according to the alert.
Applied Medical distributed a letter Nov. 8 to customers alerting them of the medical device recall and instructions on how to return the catheters, according to the alert.