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, and 39 device recalls in 2016.
See the chart above for a complete month-by-month breakdown of recalls in the medical device sector from 2016 through 2019 (as of Aug. 5, 2019).
FDA recently said it is taking new steps to strengthen and modernize the process for issuing a public warning about a voluntary recall and for notification of recalls.
"Most companies collaborate with the FDA to rapidly initiate voluntary recalls and work with their supply chain partners to remove the product from shelves to prevent further distribution," the agency noted. "And in general, a recall occurs quickly when the problem is discovered. However, there are situations where the FDA may need to provide safety advice to [the] marketplace to protect consumers."
Companies that have recalled medical devices this year include (in order from most recent): Abbott, Becton Dickinson, Teleflex, GE Healthcare, Hamilton Medical, Edwards Lifesciences, Vyaire Medical, Cook Medical, Terumo Medical, Integra Lifesciences, Beckman Coulter Lifesciences, Ethicon, Alpha Omega Engineering, Brainlab, O-Two Medical Technologies, RVO 2.0, Physio-Control, Medtronic, Smiths Medical, West Pharmaceutical Services, Terrific Care/Medex Supply, Draeger Medical.