Inspire 900-007-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10855728005366), received between Feb 8, 2018 and Mar 24, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Migration” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN AT THE IPG SITE AND SHOULDER. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, REMOVED THE IPG, CAPPED THE STIMULATION LEAD AND SENSING LEAD, AND CLOSED THE SITE.

  Patient problems: Pain

  MAUDE report 21678300 ↗
• InjuryJul 30, 2019Migration; Migration

  DURING A REVISION TO RESTORE THERAPY, EXTENSIVE DAMAGE TO THE INSPIRE SYSTEM WAS DISCOVERED RESULTING FROM TWIDDLER'S SYNDROME. THE IPG HAD BEEN FLIPPED +50 TIMES, CAUSING DAMAGE TO BOTH LEADS. THE PHYSICIAN REMOVED THE PROXIMAL SECTIONS OF THE LEADS AND RESECURED THE IPG IN THE POCKET FOR POTENTIAL FUTURE RE-IMPLANTATION. THE EXPLANT PROCEDURE TOOK PLACE ON (B)(6) 2019. I WALKED HER STEPPING UP WITH HER REMOTE. SHE GOT FROM LEVEL 6 TO 7. BUT SAYS IT WON¿T GO HIGHER. THE UPPER LIMIT LIGHT ISN¿T ON. I THINK SHE WAS JUST IMPATIENT AND NOT WAITING LONG ENOUGH TO CONNECT TO THE IPG, SINCE IT WENT UP ONE LEVEL AT FIRST. SHE NEEDS TO BE SEEN IN OFFICE. I DON¿T THINK IT¿S A REMOTE ISSUE. IT¿S POSSIBLE IT¿S JUST SOME LATER HEALING, BUT THERE MIGHT BE AN ISSUE.

  Patient problems: Twiddlers Syndrome

  MAUDE report 8843633 ↗
• InjuryJul 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUTURE ABSCESS WHICH WAS TREATED WITH 7 DAYS OF ANTIBIOTICS. NO ADDITION INTERVENTION NEEDED.

  Patient problems: Abscess

  MAUDE report 8790167 ↗
• InjuryJul 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REDNESS/SORENESS AT THE RIGHT LATERAL MIDCHEST INCISION. TREATED WITH KEFLEX AND RESOLVED WITHOUT FURTHER TREATMENT.

  Patient problems: Cellulitis

  MAUDE report 8790038 ↗
• InjuryMay 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018 PATIENT REPORTED WEEKNESS OF TOUNGE, NUMBNESS OF TONGUE AND SLIRRING OF SPEECH, DIFFICULTY SPEAKING LOUD OR PRONUNCIATING. SYMPTOMS HAVE BEEN IMPROVING, BUT ARE STILL PRESENT. APPOINTMENT FOR ACTIVATION WAS CANCELED TO ALLOW TIME FOR THIS TO RESOLVE, BUT NO INTERVENTION WAS DEEMED NECESSARY. HOWEVER, ON (B)(6) 2018 WE WERE INFORMED THAT, DESPITE FURTHER IMPROVEMENT IN SYMPTOMS, PATIENT WAS GOING TO BE SEEN BY THE PHYSICIAN IN EARLY (B)(6) 2018 TO FURTHER ASSESS SYMPTOMS.

  Patient problems: Neuropathy

  MAUDE report 7477494 ↗
• InjuryMay 1, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  PATIENT COMPLAINED OF PAIN AT INTERCOSTAL SITE. DURING PHYSICAL EXAM THE DOCTOR DETERMINED THE IPG HAD FLIPPED 180 DEGREES. PATIENT WILL LIKELY REQUIRE A REVISION SURGERY TO ADDRESS THIS IN THE NEAR FUTURE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7476973 ↗
• InjuryMay 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW UP TO 3007666314-2018-00007: PATIENT HAD AN INFECTION BUT IT WAS RESOLVED THROUGH THE USE OF ANTIBIOTICS. EXPLANT OF THE SYSTEM WAS UNNECESSARY.

  Patient problems: Post Operative Wound Infection

  MAUDE report 7476733 ↗
• InjuryFeb 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INSPIRE 3028 IPG AND LEADS WERE EXPLANTED AT PATIENTS REQUEST FOR PATIENT'S POSSIBLE ALLERGIC REACTION TO MATERIALS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 7300510 ↗
• InjuryFeb 8, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS SUCCESSFULLY IMPLANTED WITH INSPIRE SYSTEM ON (B)(6) 2017 WITH NO COMPLICATIONS. PATIENT WAS DISCHARGED FORM HOSPITAL SAME DAY. PATIENT PRESENTED TO THE ER OF A DIFFERENT FACILITY COMPLAINING OF PAIN. CLINICIANS AT THIS FACILITY NOTICED FACIAL WEAKNESS/DROOP. POSSIBLY BELIEVED THE PATIENT WAS HAVING A STROKE AND PLACED A CENTRAL LINE ON PATIENTS RIGHT SIDE, VIOLATING THE INSPIRE IPG POCKET (SUBCLAVICULAR). PATIENT WAS ADMITTED INTO THIS HOSPITAL AND IS NOW (B)(6). PATIENT WAS TRANSFERRED BACK TO IMPLANTING FACILITY AND IS UNDER THE CARE OF INFECTIOUS DISEASE. IMPLANTING PHYSICIAN WAS NOTIFIED, ALL HARDWARE WAS SUCCESSFULLY EXPLANTED ON (B)(6) 2017 AND PATIENT IS CONTINUING ANTIBIOTIC TREATMENT.

  Patient problems: Bacterial Infection

  MAUDE report 7254243 ↗

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