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).
Reported: September 12, 2018 Initiated: June 12, 2018 #Z-2969-2018
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.
Details
- Recalling Firm
- Inspire Medical Systems Inc.
- Units Affected
- 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.
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Inspire Medical Systems Inc.. Units affected: 93 devices.
Why was this product recalled? ▼
Incorrect use-by date on the device registration/patient file labels.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 12, 2018. Severity: Moderate. Recall number: Z-2969-2018.
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