Inspire Model 4063 Stimulation Lead Labeling Error — Serial Number Mismatch
Inspire Medical Systems is recalling 457 Model 4063 Stimulation Leads because the serial number on the shelf box does not match the serial number of the device inside, creating identification and traceability issues.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is a FDA Class II recall involving a labeling error with no reported injuries or illnesses. The mismatch between the shelf box serial number and the actual device serial number is a documentation issue rather than a physical hazard.
Plain-English summary
Inspire Medical Systems Inc. is recalling 457 Inspire Model 4063 Stimulation Leads, a component of the Inspire Upper Airway Stimulation (UAS) system, due to a labeling error. The serial number printed on the shelf box label does not match the serial number of the lead contained within the box, potentially compromising product identification and traceability.
The affected devices have worldwide distribution, including throughout the United States and in the following countries: Belgium, Switzerland, Germany, United Kingdom, Netherlands, and Singapore.
Patients who have received this device should contact their healthcare provider to verify that the device serial number in their medical records matches the actual device implanted. Healthcare providers should verify device serial numbers before implantation and consult Inspire Medical Systems for a complete list of affected serial numbers and guidance on the recall.
The recalled product
- Product
- Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
- Manufacturer
- Inspire Medical Systems Inc.
- Affected units
- 457
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)
- T52644
- T52642
- T52640
- T52635
- T52630
- T52634
- T52615
- T52611
- T52654
- T52655
- T52607
- T52604
- T52609
- T52603
- T52595
- T52597
- T52616
- T52594
- T52591
- T52590
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Inspire Medical Systems Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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