Inspire 900-001-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00855728005017), received between Jun 9, 2016 and Jun 12, 2018 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Computer Operating System Problem” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED ON AND WAS SENT HOME THE SAME DAY. THE PATIENT HAD GONE OFF HIS BLOOD THINNING MEDICATIONS EARLIER THAT WEEK, PRIOR TO SURGERY. HIS CARDIOLOGIST INSTRUCTED HIM TO RESUME HIS BLOOD THINNING MEDICATION 2 DAYS AFTER THE IMPLANT PROCEDURE. THE NEXT DAY HE WOKE UP AND HAD DEVELOPED A HEMATOMA AT THE SITE OF THE STIMULATION LEAD. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THE HEMATOMA AND THE BLOOD THINNERS WERE DISCONTINUED FOR 72 HRS AND HE WAS PRESCRIBED ANTIBIOTICS. THE HEMATOMA LOOKED MUCH BETTER THE FOLLOWING MORNING AND THE PATIENT WAS DISCHARGED. THE PATIENT WAS BROUGHT BACK IN ABOUT 2 WEEKS LATER AND WAS DOING WELL.

  Patient problems: Hematoma

  MAUDE report 7593885 ↗
• InjuryMay 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT PRESENTED TO CLINIC WITH STIMULATION LEAD ERODING THROUGH SKIN. SYSTEM EXPLANT WAS SCHEDULED AND PERFORMED ON (B)(6) 2018.

  Patient problems: Erosion

  MAUDE report 7477947 ↗
• InjuryMay 1, 2018No Apparent Adverse Event; Missing Value Reason; No Apparent Adverse Event; Missing Value Reason

  FOLLOW UP REPORT: PHYSICIAN CONFIRMED THAT ALL ISSUES HAVE RESOLVED INCLUDING THE FACIAL/RIGHT LOWER LIP WEAKNESS.

  Patient problems: Blood Loss

  MAUDE report 7476547 ↗
• InjuryMar 9, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  NO DEVICE MALFUNCTION BUT PATIENT HAD A SURGERY TO REPLACE STIMULATION LEAD DUE TO A POST OPERATIVE INFECTION. THIS WAS A CLINICAL STUDY PATIENT BEING FOLLOWED WITH IN A POST APPROVAL STUDY WHERE THE ADVERSE EVENT WAS FIRST MADE KNOW TO THE MANUFACTURER ON (B)(6) 2017. PARALLEL REPORTING REQUIREMENT AS A COMMERCIAL PATIENT WAS INITIALLY MISSED UNTIL RECENTLY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7327475 ↗
• InjuryOct 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS A FOLLOW UP REPORT TO MDR REPORT # 3007666314-2017-00019, FILED TO UPDATE THE REPORT WITH THE INFORMATION THAT THE INJURY COMPLETELY RESOLVED WITHOUT INTERVENTION.

  Patient problems: Nerve Damage

  MAUDE report 6987670 ↗
• InjuryJun 28, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  PATIENT REPORTED TO THE CLINIC WITH ONE CENTIMETER OF LEAD LENGTH EXTRUDED FROM THE NECK INCISION; THE PHYSICIAN DECIDED TO OPEN THE STIMULATION LEAD INCISION AND CLEAN IT UP. THE TISSUE LOOKED HEALTHY WITH NO SIGN OF INFECTION. DR IRRIGATED AND THEN CLOSED OVER GOOD HEALTHY MUSCLE AND TESTED THE DEVICE WITH GOOD RESULTS. FOLLOWED WITH TWO DAYS OF INTRAVENOUS ANTIBIOTICS FOLLOWED BY TWO WEEKS OF ORAL ANTIBIOTICS.

  Patient problems: No Code Available

  MAUDE report 6675722 ↗
• InjuryMay 15, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD BEEN PREVIOUSLY IMPLANTED WITH THE INSPIRE SYSTEM. LATER PATIENT UNDERWENT SPINAL FUSION SURGERY, UNRELATED TO HIS INSPIRE THERAPY, IN HIS NECK AREA DURING WHICH HIS STIMULATION LEAD WAS ACCIDENTALLY CUT. PATIENT CAN NO LONGER USE HIS INSPIRE THERAPY. LEAD WILL BE REPLACED AFTER THE PATIENT HAS HEALED SUFFICIENTLY FROM HIS SPINAL FUSION SURGERY.

  Patient problems: No Code Available

  MAUDE report 6568074 ↗
• InjuryMay 15, 2017Malposition of Device; Malposition of Device

  PATIENT IS EXPERIENCING TETHERING ON HIS STIMULATION LEAD DUE TO IMPROPER ROUTING OF THE LEAD AROUND THE DIGASTRIC TENDON. A REVISION SURGERY WILL BE REQUIRED TO ADDRESS THIS ISSUE.

  Patient problems: Neck Pain

  MAUDE report 6567889 ↗
• InjuryJan 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE PATIENT ACTIVATION, THERE WAS VISIBLE UNILATERAL TONGUE ATROPHY, PATIENT SAYS IT'S BEEN IMPROVING SINCE IMPLANT. SHE WAS ALSO LISPING AND HAVING PROBLEMS SWALLOWING IMMEDIATELY POST IMPLANT, BUT THAT IS NOW RESOLVED. ACTIVATION HAD HIGH FUNCTIONAL THRESHOLDS WITH MINIMAL TONGUE MOVEMENT. THIS IS POSSIBLY A CASE OF TEMPORARY NEUROPRAXIA FROM THE IMPLANT PROCEDURE, WHICH IS AN EXPECTED EVENT. ACTIVATION OF PATIENT'S THERAPY WAS POSTPONED TO ALLOW ADDITIONAL TIME FOR THEIR HYPOGLOSSAL NERVE TO HEAL FROM THE IMPLANT PROCEDURE.

  Patient problems: Nerve Damage

  MAUDE report 6271655 ↗
• InjuryDec 1, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MUCOSAL TEAR IN FLOOR OF THE MOUTH EITHER HAPPENING FROM THE BLUE NIM PROBE (ANOTHER MANUFACTURERS DEVICE) USED TO MONITOR GENIOHYOID OR FROM NERVE DISSECTION DUE TO CHALLENGING ANATOMY WHILE IMPLANTING THE MODEL 4063 STIMULATION LEAD. THE DOCTOR PLACED 3 DISPOSABLE STITCHES IN THE FLOOR OF THE PATIENTS MOUTH AND SENT HIM HOME ON ANTIBIOTICS.

  Patient problems: Tissue Damage

  MAUDE report 6139837 ↗
• InjuryOct 26, 2016Use of Device Problem; Use of Device Problem

  SURGEON NICKED THE PATIENT'S JUGULAR VEIN DURING THE IMPLANT SURGERY, SPECIFICALLY WHILE TUNNELLING IN PREPARATION FOR IMPLANT OF THE STIMULATION LEAD. THE SURGEON WAS ABEL TO STOP THE BLEEDING AND CONTINUED WITH THE IMPLANT OF THE SYSTEM. THE PATIENT IS DOING WELL AND IS RESPONDING NICELY TO THE THERAPY BUT THE PATIENTS SURGICAL PROCEDURE WAS PROLONGED BY 2.5 HOURS AS A RESULT THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 6059123 ↗
• InjuryJul 1, 2016Computer Operating System Problem

  PATIENT EXPERIENCED SWELLING OF THEIR TONGUE AFTER USING THE THERAPY WHICH WOULD RESOLVED ON ITS OWN DURING THE DAY. PATIENT DID GO TO THE ER AT ONE POINT WHEN THEIR TONGUE SWELLED OVER CONCERNS THAT IT MIGHT HAVE BEEN DUE TO A STROKE, WHICH IT WAS DETERMINED THAT IT WASN'T. PATIENT HAD DEVICE SETTINGS ADJUSTED TO PERMIT A LOWER STIMULATION AMPLITUDE AT THE BOTTOM END OF HIS STIMULATION RANGE.

  Patient problems: Swelling

  MAUDE report 5766667 ↗
• MalfunctionJun 9, 2016Device Operational Issue; Device Operational Issue

  PATIENT WAS NOT FEELING ANY STIMULATION FROM THE SYSTEM. THIS WAS ULTIMATELY RESOLVED BY ADJUSTING THE DEVICE SETTINGS, BUT PRIOR TO THIS THE PATIENT UNDERWENT AN EXTRA SURGICAL PROCEDURE TO DETERMINE WHETHER OR NOT THE STIMULATION LEAD IMPLANT NEEDED TO BE REVISED.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 5710774 ↗

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