Recall Z-2032-2020 ยท MCM Implant, Cochlear
Advanced Bionics, LLC
AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
| Date | Feb 17, 2020 |
| Status | Terminated |
| Reason | hearing performance degradation due to body-fluid entering the device. |
| Root cause | Device Design |
| Action | On 02/17/2020, the firm sent an "Urgent Field Action Notification" via email to healthcare providers informing them that the firm has detected an increase in the number of devices being explanted or the potential of being explanted due to performance issues (impedance drop and reports of hearing performance degradation) resulting from fluid ingress at the electrode. The Healthcare Notification instructs Healthcare Providers to: 1. Provide registration information for all devices that have been implanted; 2. Return any unimplanted devices and to emphasize not to implant any of these units. The |
| Quantity | 8159 units (CI-1601-04 = 3827 units and CI-1601-05 = 4332 units) |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Canada, Brazil, Bangladesh, Switzerland, China, Australia, India, South Korea, Thailand, Ecuador, Mexico, El Salvador, Guatemala, Malaysia, Myanmar, Taiwan, Chile, Costa Rica, Colombia, Panama, Japan, Argentina, Peru, Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.