Inspire II Implantable Pulse Generator Recalled for Incorrect Use-By Date
Inspire Medical Systems is recalling 93 Inspire II Implantable Pulse Generators because the device registration labels contain an incorrect use-by date.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a minor labeling error (incorrect use-by date) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Inspire Medical Systems Inc. is recalling 93 Inspire II Model 3024 Implantable Pulse Generators (IPG) for Obstructive Sleep Apnea. The recall is due to an incorrect use-by date of 2018-01-14 printed on the device registration and patient file labels found in the literature packet included with the sterile tray.
The affected devices were distributed nationwide in the states of AL, AZ, CA, FL, GA, IL, KY, MA, MI, MN, MS, NY, OH, PA, TN, TX, VA, WA, and WI. The source text lists specific serial numbers for devices in customer stock and devices that have already been implanted in patients.
Healthcare providers and patients should verify the serial numbers of their devices against the list provided in the official recall notice. If a device is affected, the manufacturer is coordinating the recall to address the labeling error.
The recalled product
- 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 wit
- Manufacturer
- Inspire Medical Systems Inc.
- Hazard
- Affected units
- 93
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- device registration form
- NCR202230H
- NCR202238H
- NCR202244H
- NCR202245H
- NCR202246H
- NCR202247H
- NCR202252H
- NCR202253H
- NCR202254H
- NCR202255H
- NCR202259H
- NCR202260H
- NCR202261H
- NCR202264H
- NCR202266H
- NCR202267H
- NCR202268H
- NCR202269H
- NCR202270H
Distribution
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