Inspire 900-002-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10855728005526), received between Apr 29, 2019 and Aug 4, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Sensing Problem” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN BELOW THE CHEST INCISION WHERE THE SENSE LEAD WAS PLACED. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, AND UPON SURGICAL EXPLORATION, IT WAS OBSERVED THAT THE SENSING LEAD WAS NOT LYING FLAT WITHIN THE INTERCOSTAL SPACE. PHYSICIAN REPOSITIONED THE SENSING LEAD, RE-SUTURED, AND CLOSED THE INCISION.

  Patient problems: Pain

  MAUDE report 22708056 ↗
• InjuryMay 30, 2025Device Sensing Problem; Device Sensing Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN AT THEIR SIDE, DESCRIBED AS A SHOCKING SENSATION AND INTERMITTENT STINGING IN THE RIBS, CAUSING SEVERE PAIN. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REMOVED THE ENTIRE INSPIRE SYSTEM.

  Patient problems: Pain

  MAUDE report 22117089 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN AT THE SENSE LEAD INCISION. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, REPLACED THE IPG, AND PLACED A NEW SENSING LEAD IN AN ALTERNATE LOCATION.

  Patient problems: Pain

  MAUDE report 19038181 ↗
• InjuryJun 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AT THE TIME OF THE REVISION SURGERY, (B)(6) 2021, THE LEAD WAS REPLACED TO RESTORE THERAPY. DURING THE REVISION, THE WHITE SILICONE TIP OF THE SENSOR WAS FOUND TO HAVE SEPARATED FROM THE LEAD BODY. THE PHYSICIAN DETERMINED THAT RETRIEVING THE SILICONE TIP WOULD EXPOSE THE PATIENT TO GREATER RISK AND DECIDED TO LEAVE THE SILICONE BEHIND IN THE PATIENT. THE REVISION SURGERY RESTORED THERAPY AND THE ISSUE IS NOW RESOLVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12042964 ↗
• InjuryNov 20, 2020Malposition of Device; Malposition of Device

  PATIENT EXPERIENCED INTERCOSTAL NERVE PAIN DUE TO THE PLACEMENT OF THE SENSE LEAD. SURGERY WAS PERFORMED ON (B)(6) 2020 TO REPOSITION THE SENSE LEAD TIP. THIS RESOLVED THE PATIENT'S ISSUE.

  Patient problems: Pain

  MAUDE report 10880689 ↗
• InjuryNov 20, 2020Device Sensing Problem; Device Sensing Problem

  PATIENT WAS IMPLANTED WITH INSPIRE SYSTEM (B)(6) 2018. PATIENT PRESENTED TO PHYSICIAN ON (B)(6) 2020 WITH PAIN AT THE SENSOR LEAD INCISION SITE AFTER USING A CHAINSAW AND A SHOTGUN. A REVISION SURGERY TO REPLACE THE SENSE LEAD TOOK PLACE ON (B)(6) 2020. DURING THE REVISION SURGERY, THE SURGEON FOUND THAT THE SENSOR LEAD DISTAL TIP WAS DETACHED THE LEAD BODY. A THORACIC SURGEON WAS CALLED INTO THE REVISION PROCEDURE TO FIND THE SENSE LEAD TIP. THE THORACIC SURGEON OPENED THE PLEURA IN AN ATTEMPT TO FIND THE TIP AND CONSEQUENTLY THE PATIENT NEEDED A CHEST TUBE. THE SENSE LEAD TIP COULD NOT BE LOCATED. PATIENT WAS COUNSELED THAT MRI IS CONTRAINDICATED.

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 10880509 ↗
• InjuryFeb 25, 2020Positioning Problem; Positioning Problem

  PATIENT CONTINUED TO HAVE PAIN FOLLOWING THE PREVIOUSLY REPORTED SURGERY TO REPOSITION THE SENSE LEAD. A 2ND SURGERY TOOK PLACE ON (B)(6) 2020 TO REPLACE THE SENSE LEAD. THIS RESOLVED THE ISSUE.

  Patient problems: Pain

  MAUDE report 9752876 ↗
• InjuryJan 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON REMOVED THE PATIENT'S SENSE LEAD IN (B)(6) DUE TO INFECTION. THE IPG AND STIMULATION LEAD BOTH ALSO BECAME INFECTED AND THE SURGEON REMOVED BOTH ON (B)(6) 2020.

  Patient problems: Bacterial Infection

  MAUDE report 9641941 ↗
• InjuryAug 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER IMPLANT ON (B)(6) 2019, THE PATIENT DEVELOPED A RASH ON HIS CHEST MEDIAL TO THE DISTAL ASPECT OF THE SENSING LEAD INCISION. ALL THREE INCISIONS LOOKED GREAT AND THE PHYSICIAN DID NOT THINK THERE WAS ANY INFECTION BUT PRESCRIBED THE PATIENT A COURSE OF ANTIBIOTICS OUT OF PRECAUTION.

  Patient problems: Rash

  MAUDE report 8932261 ↗
• InjuryApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN INFORMED INSPIRE OF A SENSE LEAD REVISION THAT TOOK PLACE ON (B)(6) 2019. PATIENT COMPLAINED OF PAIN. THE RESPIRATORY LEAD WAS READJUSTED WITHIN THE INTERCOSTAL SPACE AND THE SYSTEM TESTED INTRAOPERATIVELY.

  Patient problems: Pain

  MAUDE report 8560985 ↗

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