Inspire 900-001-007Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00855728005185), received between Oct 4, 2018 and Jul 12, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Expulsion” (1 report).

3 other recalls cover devices cleared under the same FDA submission (P130008); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED (B)(6) 2018. PATIENT CALLED (B)(6) 2018 AND WAS SEEN SAME DAY BY DR. DUE TO REPORTING RED AND OOZING NECK/CUFF INCISION WITH FEVER AND CHILLS SINCE (B)(6) 2018. (B)(6) CONFIRMED INFECTION- + GRAM STAIN PENDING CULTURE RESULTS. SHE SLIGHTLY OPENED THE SUPERFICIAL WOUND, IRRIGATED AND PACKED IT. ADMITTED PATIENT FOR IV VANCOMYACIN AND OBSERVATION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 17305350 ↗
• InjuryJun 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POSTOPERATIVE CELLULITIS AROUND THE SUBMANDIBULAR INCISION, WHICH DEVELOPED AFTER THE SUBJECT PICKED OFF THE SURGICAL DRESSING. FULLY RESOLVED AFTER ADMINISTERING ORAL MEDICATIONS.

  Patient problems: Cellulitis

  MAUDE report 8707899 ↗
• MalfunctionApr 29, 2019Expulsion; Expulsion

  THE PHYSICIAN'S OFFICE INFORMED INSPIRE ON (B)(6) 2019 OF A PATIENT WHO HAD EXPERIENCED AN ADVERSE EVENT IN (B)(6) 2018 WHEN THE PATIENT'S SIMULATION WIRE TEMPORARILY EXTRUDED FROM THE SKIN AFTER LIFTING A 200-POUND PIECE OF SHEETROCK. INSPIRE PERSONNEL WAS NOT AWARE OF THE ISSUE AND THE PHYSICIAN'S OFFICE WAS CONTACTED (B)(6) 2019 FOR ADDITIONAL INFORMATION. THE PHYSICIAN DID NOT SEE THE PATIENT IN THE OFFICE AND PRESCRIBED BACTRIM REMOTELY. THE PHYSICIAN INDICATED THAT THE EVENT WAS NON-SERIOUS AND RESOLVED (B)(6) 2018.

  Patient problems: Tissue Damage

  MAUDE report 8562401 ↗
• InjuryOct 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED (B)(6) 2018. PATIENT CALLED (B)(6) 2018 AND WAS SEEN SAME DAY BY DR. DUE TO REPORTING RED AND OOZING NECK/CUFF INCISION WITH FEVER AND CHILLS SINCE (B)(6) 2018. DR. DHANDA CONFIRMED INFECTION- + GRAM STAIN PENDING CULTURE RESULTS. SHE SLIGHTLY OPENED THE SUPERFICIAL WOUND, IRRIGATED AND PACKED IT. ADMITTED PATIENT FOR IV VANCOMYACIN AND OBSERVATION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 7936276 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P130008. One submission often covers many models, so check the product and lot details in each record.

• Z-2515-2026 · May 11, 2026 · Open, Classified
  Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire Respirato
• Z-2516-2026 · May 11, 2026 · Open, Classified
  Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire Stimulation Lead (Model 4063) is design
• Z-2969-2018 · Jun 12, 2018 · Terminated
  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 Inspir