Following dozens of reports involving problems where catheter tips broke or separated during medical procedures, the FDA has announced a recall for Bard Emblectomy Catheters, Python Embolectomy Catheters and OTW Latis Cleaning Catheters, which may result in blood vessel damage and the need for immediate surgical intervention.
The Applied Medical catheter recall was categorized as a Class I medical device recall, due to the risk that tips may become lodged in a patient’s blood vessels and obstruct blood flow, resulting in serious injury or death.
The recall involves three variations of Applied Medical latex balloon catheters, used for clearing temporary blockages in blood vessels, opening blood vessels, or administering infusion fluids.
The action was initially issued by the manufacturer in October 2019, but has since been elevated to a Class I recall by the FDA following 46 adverse health reports where the catheter tip broke or separated, with some requiring emergency surgical intervention. The FDA has become aware of at least three medical device reports (MDRs) and no reports of death or injury.
The recall includes approximately 19,400 Python Embolectomy Catheters with model numbers A4E01, A4E02, A4E03, A4E04, A4E05, A4E06, A4E08, A4E09; Bard Embolectomy Catheters with model numbers CE0340DR, CE0380DR , CE0440DR,CE0480DR CE0540DR, CE0580DR, CE0680DR; and OTW Latis Cleaning Catheters with model number A4GW6.
The catheters were manufactured by Applied Medical of Rancho Santa Margarita, California, from July 23, 2015 to November 8, 2018. They were distributed to medical facilities nationwide from August 25, 2015 to March 1, 2019.
On November 8, 2019, Applied Medical issued a Medical Device Recall Letter to all of its customers, informing them of the issue and instructing them to stop using the devices immediately.
The recent upgrade to a Class I recall indicates the catheter problems could lead to serious and potentially life threatening health consequences, including emergency surgery to remove the tip of the balloon pieces, damage to blood vessels, thrombosis, or even death.
The FDA categorizes recalls by the level of risk associated with products. The agency has categorized the Applied Medical catheter recall as a Class I recall, indicating it is the most serious of its kind and that the use of the products has a high probability of resulting in serious patient injury or death.
Customers are being asked to fill out the Recall Notification Confirmation Form and return it to Applied Medical by email to firstname.lastname@example.org or by fax to 949-713-8908.
For additional questions or concerns regarding the recall, customers should contact Applied Medicals Customer Relations at 949-713-8688 or email email@example.com.