Inspire 900-001-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10855728005397), received between Jul 10, 2018 and Jul 21, 2025 — classified as 26 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (4 reports).

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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH THE STIMULATION LEAD ERODED THROUGH THE SKIN AT THE NECK INCISION SITE AND AN INFECTION. PATIENT ALSO REPORTED SWELLING AND REDNESS ABOVE THE SENSING LEAD INCISION SITE THAT WAS PAINFUL TO TOUCH. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REMOVED THE ENTIRE INSPIRE SYSTEM. ANTIBIOTICS WERE PRESCRIBED TO THE PATIENT.

  Patient problems: Erosion; Pain; Unspecified Infection

  MAUDE report 22559930 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER ELECTIVELY HAVING THE INSPIRE DEVICE REMOVED, THE PATIENT PRESENTED TO THE PHYSICIAN, 4 DAYS POST-OP, WITH AN INFECTION AT THE NECK INCISION. PHYSICIAN ADMITTED THE PATIENT AND PLACED THEM ON IV ANTIBIOTICS AND STEROIDS. PATIENT WAS DISCHARGED TWO DAYS LATER. THIS RESOLVED THE ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 19088934 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE IMPLANT PROCEDURE, THE PHYSICIAN ENCOUNTERED A BRANCH OF THE ANTERIOR JUGULAR. PATIENT PRESENTED TO THE PHYSICIAN WITH SUBCUTANEOUS ECCHYMOSIS, NECK TIGHTNESS, AND DISCOMFORT. PHYSICIAN PRESCRIBED TORADOL FOR PAIN RELIEF.

  Patient problems: Hematoma; Perforation of Vessels

  MAUDE report 17171688 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE IMPLANT PROCEDURE, THE PHYSICIAN TUNNELED AND ENCOUNTERED AN ECTATIC ANTERIOR JUGULAR VEIN. A NECK INCISION WAS MADE FOR VESSEL CONTROL.

  Patient problems: Perforation of Vessels

  MAUDE report 17135926 ↗
• InjuryMay 1, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  PATIENT PRESENTED TO THE PHYSICIAN WITH STIMULATION LEAD PROTRUDING FROM HIS NECK. THE PHYSICIAN SURGICALLY REMOVED THE STIMULATION LEAD ON (B)(6) 2020. PATIENT WAS SEEN FOR FOLLOW UP ON 28 APR 2020 WITH NO SIGNS OF INFECTION OR FURTHER COMPLICATIONS. ISSUE IS RESOLVED.

  Patient problems: Erosion

  MAUDE report 10018681 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ONE DAY AFTER IMPLANT, A PATIENT HAD SIGNIFICANT SWELLING AND COMPLAINED OF DIFFICULTY SWALLOWING. THE PHYSICIAN BROUGHT THE PATIENT BACK TO THE OPERATING ROOM AND REMOVED A HEMATOMA. A CLOT WAS REMOVED AND SURGICEL WAS USED TO AID IN STOPPING THE BLEEDING.

  Patient problems: Hematoma

  MAUDE report 9751858 ↗
• InjuryFeb 25, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PATIENT PREVIOUSLY HAD AN INFECTION AT THE STIMULATION LEAD INCISION REPORTED IN 3007666314-2019-00025. THE INFECTION HAD RESOLVED WHEN A DERMATOLOGIST BIOPSIED THE AREA. THE LEAD WAS EXPOSED WITHOUT INFECTION AFTER THE BIOPSY. THE FULL SYSTEM WAS REMOVED (B)(6) 2020 DUE TO INFECTION RISK.

  Patient problems: Erosion

  MAUDE report 9751849 ↗
• InjuryJan 30, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PHYSICIAN SURGICALLY REMOVED THE STIMULATION LEAD ON (B)(6) 2020. FOLLOWING SURGERY, THE PATIENT WAS PRESCRIBED A 6 WEEK COURSE OF ANTIBIOTICS TO PREVENT INFECTION. THE PATIENT'S ISSUE IS NOW RESOLVED.

  Patient problems: Erosion

  MAUDE report 9649256 ↗
• InjuryDec 13, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  EROSION OF THE STIMULATION LEAD AT THE MANDIBLE. STIMULATION LEAD AND IPG SURGICALLY REMOVED (B)(6) 2019.

  Patient problems: Erosion

  MAUDE report 9467643 ↗
• InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT FOLLOW UP INDICATED THAT THE ISSUE IS NOT COMPLETELY RESOLVED BUT THE PATIENT IS DOING FINE AND CLOSE TO NORMAL OVERALL AND LIKELY AS GOOD AS EXPECTED.

  Patient problems: Nerve Damage

  MAUDE report 9282080 ↗
• InjuryJun 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN IMPLANT PROCEDURE, THE PHYSICIAN HIT AN UNEXPECTED BLOOD VESSEL DURING THE TUNNELING PORTION OF THE CASE. THE PHYSICIAN MADE AN EXTRA INCISION TO ENSURE ALL BLEEDING WAS CONTAINED. THEY SEARCHED UNTIL NO BLEEDING WAS OBSERVED WITH VALSALVA, THEN CLOSED THE INCISION. THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION AND THE ISSUE RESOLVED WITH NO HEMATOMA.

  Patient problems: Perforation of Vessels

  MAUDE report 8728209 ↗
• InjuryJun 10, 2019Expulsion; Expulsion

  THE PATIENT PRESENTED WITH THE STIMULATION LEAD WIRE PARTIALLY EXTRUDED OUT OF THEIR SURGICAL INCISION. THE SURGEON EXAMINED THE LEAD UNDER A SCOPE TO ACCESS FOR ANY DAMAGE AND RAN PROGRAMMING TESTS TO ENSURE THE LEAD WAS INTACT. THE PHYSICIAN THEN PROCEEDED WITH DEBRIDEMENT AND CLEANING OF THE WOUND. THE PHYSICIAN RE-MANEUVERED THE LEAD TO LIE FLAT AND CLOSED THE WOUND WITHOUT FURTHER INCIDENT.

  Patient problems: Erosion

  MAUDE report 8683894 ↗
• InjuryApr 29, 2019Malposition of Device; Malposition of Device

  THE PHYSICIAN REPLACED A PATIENT'S STIMULATION LEAD WHICH HAD BEEN IMPLANTED TOO SUPERFICIALLY. THE REVISION WAS SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8561330 ↗
• InjuryApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE IMPLANTATION OF THE INSPIRE STIMULATION LEAD, THE PATIENT'S EXTERNAL JUGULAR VEIN WAS LACERATED DURING TUNNELING. THE BLEEDING WAS NOT EASILY CONTROLLED AND MORE ADVANCED INTERVENTION WAS NEEDED. THE SURGEON MADE A SECONDARY INCISION APPROXIMATELY 5CM LONG AND 5CM BELOW THE PRIMARY STIMULATION LEAD INCISION. THIS ALLOWED ACCESS TO THE SOURCE OF THE BLEEDING AND HE WAS ABLE TO DELIVER THE PROPER INTERVENTION TO CONTROL THE BLEED.

  Patient problems: Blood Loss; Perforation of Vessels

  MAUDE report 8561202 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN TREATED AN INFECTION AT THE STIMULATION LEAD WITH BACTRIM OVER THE COURSE OF 5 MONTHS. PHYSICIAN REPORTS THAT THERE IS NOW NO EVIDENCE OF ONGOING INFECTION.

  Patient problems: Bacterial Infection

  MAUDE report 8537439 ↗
• InjuryMar 22, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  THE STIMULATION LEAD WAS REMOVED 26 APRIL 2019, WHICH RESOLVED THE ISSUE.

  Patient problems: Erosion

  MAUDE report 8444643 ↗
• InjuryMar 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INFECTION WAS RECURRENT AND THE PHYSICIAN REFERRED THE PATIENT TO ID FOR PICC LINE AND IV ANTIBIOTICS. AFTER TREATMENT, THE INFECTION WAS RESOLVED WITHOUT FURTHER SURGICAL INTERVENTION.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 8444515 ↗
• InjuryFeb 28, 2019Migration; Migration

  THE PATIENT COMPLAINED OF PAIN IN THE INTERCOSTAL INCISION SITE. THE ISSUE WAS RESOLVED BY REPOSITIONING THE SENSOR LEAD AT REVISION ON (B)(6) 2019. NO NEW PRODUCT WAS IMPLANTED, THE ORIGINALLY IMPLANTED BREATHING SENSOR WAS REPOSITIONED.

  Patient problems: No Code Available; Pain

  MAUDE report 8377772 ↗
• InjuryFeb 27, 2019Malposition of Device; Malposition of Device

  STIMULATION LEAD WAS IMPLANTED TOO SUPERFICIAL AND NEEDED A REVISION PROCEDURE TO BE RE-TUNNELED DEEPER.

  Patient problems: No Code Available

  MAUDE report 8376189 ↗
• InjuryFeb 13, 2019Positioning Failure; Positioning Failure

  SCHEDULED REVISION REFERENCED IN THE INITIAL REPORT WAS COMPLETED (B)(6) 2019 WITHOUT ISSUES RESOLVING THE INITIAL COMPLAINT.

  Patient problems: No Code Available

  MAUDE report 8337038 ↗
• InjuryDec 20, 2018Appropriate Device Problem Term/Code Not Available

  FOLLOW UP REPORT TO 3007666314-2018-00053: PATIENT REPORTED THE STIMULATION LEAD TRACTION AND PAIN. THE ISSUE WAS RESOLVED BY RE-TUNNELING THE STIMULATION LEAD AND REPOSITIONING THE IPG. BASED ON THE ABOVE INFORMATION, THE ROOT CAUSE WAS CONCLUDED AS SUB-OPTIMAL IMPLANT LOCATION/DEPTH/SIZE.

  Patient problems: Neck Pain

  MAUDE report 8184890 ↗
• InjuryNov 12, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  SURGEON INADVERTENTLY CUT THE DIGASTRIC TENDON DURING THE STIMULATION LEAD IMPLANTATION. THE TENDON WAS SURGICALLY REPAIRED DURING THE IMPLANT PROCEDURE. IMPLANT PROCEEDED WITHOUT FURTHER INCIDENT OR COMPLICATION.

  Patient problems: Tissue Damage

  MAUDE report 8060053 ↗
• InjurySep 4, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT IS EXPERIENCING TRACTION ON THE STIMULATION LEAD. MAY REQUIRE MEDICAL INTERVENTION TO ADDRESS.

  Patient problems: Neck Pain

  MAUDE report 7842800 ↗
• InjuryAug 15, 2018Positioning Problem; Positioning Problem

  PATIENT IS EXPERIENCING TRACTION ON THE STIMULATION LEAD. PHYSIICAN WILL BE SCHEDULING A REVISION SURGERY TO ADDRESS THE ISSUE.

  Patient problems: No Code Available

  MAUDE report 7787295 ↗
• InjuryAug 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR CALLED REGARDING A PATIENT WHO MAY HAVE AN INFECTED INCISION FOR THE STIMULATION LEAD IMPLANT. HE CULTURED THE SITE ON (B)(6) 2018 AND IS AWAITING PATHOLOGY REPORT. IN THE MEANTIME HE HAS BEGUN A COURSE OF ANTIBIOTICS AND UPON CONFIRMATION OF PATHOLOGY WILL DETERMINE IF EXPLANT IS NECESSARY.

  Patient problems: Post Operative Wound Infection

  MAUDE report 7787162 ↗

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-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-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-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