Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Soft
FDA device recall Z-2515-2026 · posted 2026-06-18 · Open, Classified
Recall details
- Recalling firm
- Inspire Medical Systems Inc.
- Reason for recall
- Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.
- Action taken
- Firm began notifying consignees on May 11, 2026. Letters were titled "URGENT Medical Device Correction." The firm requests consignees' assistance in removing affected product from clinical inventory and returning them to Inspire.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- MNQ
- Quantity affected
- 50 impacted units
- Distribution
- Worldwide distribution - US Nationwide and the country of Hong Kong.
- Date initiated
- 2026-05-11
- Date posted
- 2026-06-18
- Location
- Golden Valley, MN
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