Abbott & #039;s Ellipse Recall Is the 33rd U.S. Medical Device Recall This Year

Abbott is recalling the Ellipse Implantable Cardioverter Defibrillators (ICDs) because electrical failures have been identified and determined to be due to a faulty manufacturing process causing some aluminum wires to be partially exposed. ICDs, which contain aluminum wires that are not fully insulated are prone to electrical shorting of the capacitor.  The potential patient impact could be the inability to deliver high voltage therapy. There is currently no available method or procedure to determine which of these devices have this issue prior to failure. Abbott said it is not aware of any reports of this failure occurring in any affected implanted devices. Of the devices recalled, 31 have been implanted in U.S. patients. The complaints and medical device reports (MDRs) available have either reported that the affected devices have been replaced or are scheduled to be replaced with another ICD generator. None of the complaint or MDRs indicate that any patient harm or adverse events have occurred, and no deaths have been reported. The 108 Ellipse ICDs affected by this recall were manufactured between April 5, 2019, and May 29, 2019. The devices were distributed between May 6, 2019, and June 14, 2019. FDA has reported a total of 33 medical device recalls so far this year compared to 14 device recalls this time last year, and a total of only 32 device recalls the entire year, according to FDA's database. The agency also reported 32 device recalls in 2017,...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news