FDA has categorized Applied Medical’s recall of 19,400 catheters from the U.S. market as a Class I event, indicating the devices have the potential to cause serious injuries or death.
The classification, which the agency disclosed Tuesday, comes seven months after Applied Medical initiated the recall in response to reports of tips separating during use of the catheters.
According to FDA, there have been 46 complaints related to the Applied Medical catheters since 2015. The agency has received three medical device reports, none of which detail injuries or deaths linked to the detachment of catheter tips.
The Python, Bard and Latis brand devices covered by the recall are latex balloon catheters used in the infusion of fluids and temporary blockage of blood vessels. If the catheter tip breaks off, further surgery could be required to remove it from the patient. Worse still, the dislodged tip could damage a blood vessel, leading to complications up to and including death.
In a notice shared with European customers last year, Applied Medical described the recall as a Class II event. In FDA’s view, the fault could cause serious injury or death, though, leading the agency to class the fault as its most serious type of recall. The problem affects 28,799 catheters made between August 2015 and March 2019. In the U.S., the recall applies to 19,400 devices.
The Applied Medical recall marks the second time in 2020 that FDA has categorized the withdrawal of an embolectomy catheter as a Class I event. In April, FDA shared details of a Class I recall involving LeMaitre Vascular’s 5F Plus Over the Wire Embolectomy. That recall also related to a problem that could lead to tip separation.
The back-to-back recalls by Applied Medical and LeMaitre Vascular aren't necessarily indicative of the historical record of embolectomy catheters. In the decade up to the start of 2020, FDA issued one Class I recall notice for a device covered by the embolectomy catheter product code, per a search of FDA's recall database. That notice, which FDA issued in 2016, applied to Boston Scientific’s Fetch 2.
The unusually busy period for Class I catheter recalls is part of a broader uptick in the frequency with which FDA is categorizing faults as high-risk problems. So far in 2020, the agency has issued 17 Class I recall notices. As many of the notices cover multiple related products, the number of individual device types subject to Class I recalls is 65. At this point in 2019, FDA had issued 14 notices. The comparable figure for 2018 was even lower, according to FDA's recall database.