Recall Z-2969-2018— Inspire Medical Systems Inc.
Class II · Terminated
Class II FDA medical device recall by Inspire Medical Systems Inc., initiated 2018-06-12, terminated 2019-05-21. FDA's recall record names no specific 510(k) clearance for this event. Product: 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).. Reason: Incorrect use-by date on the device registration/patient file labels..
- Recalling firm
- Inspire Medical Systems Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-12
- Terminated
- 2019-05-21
- Firm location
- Maple Grove, MN, United States
Product description
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).
Reason for recall
Incorrect use-by date on the device registration/patient file labels.
Data sourced from openFDA. This site is unofficial and independent of the FDA.