Updated with information from an Abbott spokesperson.
The FDA today issued a Class I recall label for the safety notice Abbott (NYSE:ABT) issued for its MitraClip device over issues in which the clip delivery system could not be detached from the clip due to a malfunction.
Class I recall designations, the agency’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The federal watchdog said Abbot received reports of cases in which the clip delivery system could not be detached and required open heart surgery to retrieve the delivery system. The agency warned of serious adverse health consequences, including serious patient injury or death.
The FDA said it Abbott received a total 9 reports of malfunctions, with 1 death related to the issue.
There are a total of 3,534 units in operation, with 41 lot numbers, which are affected by the safety notice. The units were manufactured between July 14, 2015 and August 11, 2015, and distributed between August 28, 2015 and February 3, 2016.
Abbott said it sent its 1st safety notice to all physicians using the device in February, instructing them with revised deployment sequence instructions, updated training with Abbot reps and to share the updated information to all pertinent staff.
In February, Abbott warned surgeons about a potential issue with its MitraClip after receiving 9 reports of problems that led to surgical interventions.
In a Feb. 4 urgent field safety notice, Abbott Vascular said the reports indicated that the delivery system for the MitraClip device, which is designed to repair the heart’s mitral valve, malfunctioned during implantation procedures. In 1 of the cases the patient died after the procedure due to “severe comorbidities,” according to the notice.
