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).
FDA Recall Z-2969-2018 · Posted None
Recalling FirmInspire Medical Systems Inc.
Recall StatusTerminated
Product CodeMNQ
Date Initiated2018-06-12
Date Terminated2019-05-21
Product Quantity93 devices
Reason for Recall
Incorrect use-by date on the device registration/patient file labels.
Firm 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.
Root Cause
Error in labeling
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.