Recall Z-2969-2018 ยท MNQ Stimulator, Hypoglossal Nerve, Implanted, Apnea
Inspire Medical Systems Inc.
Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients with moderate to severe obstructive sleep apnea (OSA).
| Date | Jun 12, 2018 |
| Status | Terminated |
| Reason | Incorrect use-by date on the device registration/patient file labels. |
| Root cause | Error in labeling |
| Action | The firm's sales team members called all of the affected implanting surgeons between 6/12-14/2018 to discuss the recall. The recalling firm issued "Dear Health Care Provider" letters dated 6/15/2018 via certified mail on 6/15/2018 to all implanting surgeons and hospital customers. The letter identified the affected product, problem and actions to be taken. For questions call 1-763-205-7974. |
| Quantity | 93 devices |
| Distribution | US Nationwide Distribution in the states of AL, AZ, CA, FL, GA, IL, KY, MA, MI, MN, MS, NY, OH, PA, TN, TX, VA, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.