Recall Z-2159-2024— Inspire Medical Systems Inc.
Class I · Ongoing
Class I FDA medical device recall by Inspire Medical Systems Inc., initiated 2024-05-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Inspire Model 3028, IV Implantable Pulse Generator. Reason: There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG,.
- Recalling firm
- Inspire Medical Systems Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-05-16
- Firm location
- Golden Valley, MN, United States
Product description
Inspire Model 3028, IV Implantable Pulse Generator
Reason for recall
There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG,
Data sourced from openFDA. This site is unofficial and independent of the FDA.