Inspire 900-002-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00855728005000), received between Feb 9, 2016 and Jan 15, 2019 — classified as 14 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN CONTACTED INSPIRE BY TEXT MESSAGE STATING THAT A PATIENT HAD A MINOR PNEUMOTHORAX ON X-RAY POST OP. NO SIGNS OF PROBLEMS INTRAOPERATIVELY AND THE PATIENT WAS TOTALLY ASYMPTOMATIC, BUT VERY CLEAR SMALL PNEUMO ON POST-OP X-RAY. NO ADDITIONAL FOLLOW-UP OR INTERVENTION IS EXPECTED FROM THIS.

  Patient problems: Pneumothorax

  MAUDE report 8249905 ↗
• InjuryNov 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED A PNEUMOTHORAX DURING THE IMPLANT WHICH WAS ADDRESSED DURING THAT PROCEDURE. PATIENT WAS MONITORED FOLLOWING IMPLANT AND IS DOING WELL.

  Patient problems: Pneumothorax

  MAUDE report 8117877 ↗
• InjuryOct 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED (B)(6) 2018 AND SUBSEQUENTLY DEVELOPED AN INFECTION AT THE SENSING LEAD IMPLANT SITE. PATIENT HAS BEEN PUT ON ANTIBIOTIC TREATMENT AND HAD THE ENTIRE INSPIRE SYSTEM EXPLANTED ON (B)(6) 2018.

  Patient problems: Unspecified Infection

  MAUDE report 8014769 ↗
• InjurySep 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN REPORTED PATIENT IS EXPERIENCING AN INFECTION AT THE SITE OF THE SENSING LEAD IMPLANT. MEDICAL INTERVENTION TO TREAT THE INFECTION IS LIKELY.

  Patient problems: Post Operative Wound Infection

  MAUDE report 7907871 ↗
• MalfunctionAug 28, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  NO PATIENT INJURY BUT THE SENSOR LEAD PRODUCED ABNORMAL WAVEFORMS. PATIENT CONTINUED TO USE THERAPY ANYWAY FOR A WHILE BUT EVENTUALLY HAD A REVISION PROCEDURE TO REPLACE THE SENSOR LEAD TO ADDRESS ELECTRICAL LEAKAGE FROM THE ORIGINAL LEAD.

  Patient problems: No Code Available

  MAUDE report 7824466 ↗
• MalfunctionJul 16, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  FOLLOW UP TO PREVIOUS REPORT (3007666314-2018-00018). PATIENT REQUIRED REVISION SURGERY TO ADDRESS PAIN FROM SENSOR LEAD PLACEMENT. REVISION SURGERY TO REPLACE THE LEAD IN A DIFFERENT POSITION WAS CONDUCTED ON (B)(6) 2018. THE SURGERY WAS COMPLETED WITH OUT ANY ADVERSE EVENTS AND APPEARS TO HAVE ADDRESSED THE ISSUE.

  Patient problems: Pain

  MAUDE report 7691464 ↗
• InjuryJun 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WHILE INSERTING THE BREATHING SENSOR THE PHYSICIAN ACCIDENTALLY ENTERED INTO THE PLEURAL SPACE. A THORACIC SURGEON WAS CALLED INTO THE ROOM TO CONFIRM THERE WAS NO PNEUMOTHORAX. HE INSTRUCTED THE SURGEON TO SUTURE THE MUSCLE OVER BACK TOGETHER OVER THE PLEURAL SPACE AND USE THE RIB SPACE ABOVE THE ONE HE WAS WORKING WITH TO INSERT THE BREATHING SENSOR. THE REMAINDER OF THE PROCEDURE WAS COMPLETED WITH NO ISSUES. THE ENT ELECTED TO KEEP THE PATIENT OVERNIGHT FOR OBSERVATION.

  Patient problems: Tissue Damage

  MAUDE report 7653227 ↗
• InjuryMay 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO DEVICE MALFUNCTION BUT PATIENT DEVELOPED A HEMOTOMA NEAR SITE OF SENSOR LEAD POST IMPLANT WHICH REQUIRED ANTIBIOTICS TO TREAT. EVENT FULLY RESOLVED.

  Patient problems: Bruise/Contusion

  MAUDE report 7558974 ↗
• InjuryOct 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE TIME OF IMPLANT WHILE ANCHORING THE SENSING LEAD, THE SURGEON NOTICED SOME AIR BUBBLES FROM THE LEAD TRACT. SHE WAS CONCERNED WITH POSSIBLE PNEUMOTHORAX SO SHE INJECTED SOME SALINE AND ASKED ANESTHESIA FOR SOME MANUAL BREATHS. DID NOT NOTICE ANYTHING MORE SO SHE CONTINUED WITH PROCEDURE. SHORTLY AFTER, WHEN ANCHORING THE SECOND ANCHOR MORE AIR BUBBLES WERE NOTICED. SHE CALLED FOR XRAY POST IMPLANT BEFORE WAKING THE PATIENT. XRAY READ BY RADIOLOGIST AND A PNEUMOTHORAX WAS DETECTED. THE PATIENT RETURNED TO HOSPITAL AND WAS ADMITTED AND A CHEST TUBE WAS INSERTED TO TREAT THE PNEUMOTHORAX.

  Patient problems: Pneumothorax

  MAUDE report 6988423 ↗
• InjuryOct 30, 2017No Apparent Adverse Event; No Apparent Adverse Event

  PATIENT CAME IN FOR HIS ACTIVATION APPOINTMENT YESTERDAY AFTERNOON AND INFORMED US THAT HE HAD A SLIGHT INFECTION IN HIS BREATHING SENSOR INCISION. PATIENT SAID HE SAW THE NURSE PRACTITIONER FOR HIS POST-OP VISIT WHO PUT HIM ON ANTIBIOTICS FOR SEVERAL WEEKS WHICH RESOLVED THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6988197 ↗
• InjuryOct 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF SENSOR LEAD FOR ONGOING PAIN. PATIENT HAD PERSISTENT PAIN IN THE INTERCOSTAL SPACE WHERE SENSOR LEAD WAS PLACED ABOUT 3 MONTHS AFTER THE SURGERY. DR. WAS MONITORING THIS PATIENT AS HE WAS NOT SURE IF IT WAS THE LEAD OR SOMETHING CERVICAL THAT WAS CAUSING THIS PAIN. WE HAD DONE A SYSTEM/COMPLIANCE CHECK AND PATIENT WAS DOING WELL IN THAT REGARD. LATER IT WAS DETERMINED THAT THE LEAD WAS PRESSING INTO A NERVE BRANCH. DR. DECIDED TO MOVE IT DOWN A LEVEL TO RELIEVE THE PAIN.

  Patient problems: Pain

  MAUDE report 6987935 ↗
• InjuryMar 28, 2017No Apparent Adverse Event; No Apparent Adverse Event

  SURGEON COMPLETED AN INSPIRE SYSTEM IMPLANT FOR A PATIENT AT (B)(6) MEDICAL CENTER ON (B)(6) 2017. DURING PREPARATION OF THE SENSOR LEAD LOCATION HE FELT THE RIBBON RETRACTOR PENETRATED NEAR THE PLEURA POTENTIALLY THROUGH THE EXTERNAL AND INTERNAL INTERCOSTAL MUSCLES. HE HALTED PREPARATION OF THE SENSOR SPACE AND TOOK ACTION TO ASSES FOR POTENTIAL PNEUMOTHORAX. WITH ASSISTANCE FROM ANESTHESIA HE IRRIGATED THE INCISION SITE WHILE THE LUNGS WERE EXPANDED. A SMALL AMOUNT OF AIR BUBBLES WAS NOTED INITIALLY BUT RESOLVED UPON FURTHER TESTING. LUNG VOLUME REMAINED STABLE DURING TESTING AND AFTERWARD DURING SUCCESSFUL PLACEMENT OF THE SENSOR AND COMPLETION OF THE IMPLANT PROCEDURE. THE PATIENT REMAINED STABLE FOR THE REMAINDER OF THE CASE AND DURING TIME IN POST OP. THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION WHICH WAS PRE-PLANNED PRIOR TO THE CASE AND REMAINED ASYMPTOMATIC UPON DISCHARGE. OBSERVATION OF SURGEON AND INSPIRE PERSONNEL WAS THAT THE RIBBON RETRACTOR USED FOR THE CASE WAS MORE RIGID THAN THE RECOMMENDED RUGGLES AND MAY HAVE CONTRIBUTED TO THE DEEPER PLANE. A RUGGLES RETRACTOR WAS USED DURING AN EARLIER CASE WITHOUT INCIDENT.

  Patient problems: Pneumothorax

  MAUDE report 6440179 ↗
• InjuryFeb 8, 2017Insufficient Device Problem Information

  I DISCUSSED THE FEASIBILITY PATIENT WHO REPORTED A POTENTIAL IMPLANT-RELATED INFECTION WITH THE DR. THE INVOLVED PATIENT HAD THE IPG REMOVED ABOUT 2 YEARS AGO DUE TO A COMPLAINT OF DISCOMFORT WITHOUT ANY INFECTION SIGNS. THE CURRENT INFECTION WAS REPORTED IN THE IPG POCKET AND SENSE LEAD AREA RECENTLY. THE SENSE LEAD REGION BECAME SENSITIVE AND SHOWED CLEAR SIGNS OF INFECTION AFTER THE ANTIBACTERIAL TREATMENT. THE SOURCE OF THE INFECTION IS UNKNOWN. THE DR. REMOVED THE SENSE LEAD TO ADDRESS THE INFECTION AND HAS SHIPPED THE EXPLANTED LEAD TO INSPIRE.

  Patient problems: Unspecified Infection

  MAUDE report 6312867 ↗
• InjuryDec 28, 2016Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2016. THE PATIENT WAS POST BILATERAL MASTECTOMY AND SUBSEQUENT RADIATION TREATMENT. THE RIGHT SIDE OF THE CHEST WALL DEMONSTRATED MORE THINNING OF THE SKIN AND SUBCUTANEOUS TISSUES THAN THE LEFT. THE IPG WAS PLACED IN A SUBCUTANEOUS POCKET ON THE LEFT SIDE, AND THE SKIN/SUBCUTANEOUS LAYER NOTED TO BE THIN. ON POSTOPERATIVE DAY SEVEN THE PATIENT PRESENTED FOR WOUND INSPECTION AND SUTURE REMOVAL. A PATCH OF CRUSTED SKIN 1 CM IN DIAMETER WAS NOTED AT THE INFERIOR MARGIN OF THE IMPLANT. OVER THE NEXT THREE WEEKS THIS AREA DECLARED ITSELF AS A FULL THICKNESS NECROSIS OF SKIN AND THE IMPLANT BECAME VISIBLE. THE DAY FOLLOWING THIS OBSERVATION THE PATIENT WAS BROUGHT TO SURGERY WHERE THE IPG POCKET WAS REOPENED, PURULENCE NOTED, AND THE IMPLANT REMOVED FROM THE WOUND WITH SENSING AND STIMULATION WIRES UNDISTURBED. THE POCKET WAS DEBRIDED OF GRANULATION AND CAPSULE TISSUE AND IRRIGATED WITH ANTIBIOTIC SOLUTION. THE UNIT WAS REPLACED INTO A SUB PECTORALIS MUSCLE POCKET AND SECURED AND THE WOUND SUTURED. POSTOPERATIVE COURSE WAS UNEVENTFUL. PATIENT WAS REFERRED TO INFECTIOUS DISEASE AND APPROPRIATE ANTIBIOTIC THERAPY INSTITUTED. IMPLANT ACTIVATION AND TITRA

  Patient problems: Post Operative Wound Infection

  MAUDE report 6209708 ↗
• InjuryOct 31, 2016Device Abrasion From Instrument Or Another Object; Device Abrasion From Instrument Or Another Object; Insufficient Device Problem Information

  PATIENT PRESENTED AT DR.'S OFFICE WITH A GOLF BALL SIZE MASS NEAR THE SENSING LEAD INCISION. LOOKED A LITTLE SWOLLEN BUT THE SKIN WAS NORMAL. DR. SAID IT WAS FIRM AND MOBILE BUT NOT TENDER. PATIENT IS BEING BROUGHT BACK FOR AN ADDITIONAL DR VISIT AND FOR A CHECK TO ENSURE THE INSPIRE SYSTEM IS FUNCTIONING NORMALLY.

  Patient problems: Seroma

  MAUDE report 6068193 ↗
• MalfunctionFeb 9, 2016Naturally Worn; Naturally Worn

  THE PATIENT EXPERIENCED EPISODES WHERE THE SYSTEM'S STIMULATION DID NOT WORK PROPERLY, SPECIFICALLY IT WOULD FEEL WEAKER THAN NORMAL. A CHECK OF THE SYSTEM SHOWED THAT THE PATIENT'S STIMULATION SENSATION THRESHOLD HAD NEARLY DOUBLED. THE SYSTEM WAS EXPLANTED AND A NEW SENSING LEAD AND IMPLANTABLE PULSE GENERATOR WERE IMPLANTED. THE EXPLANTED DEVICES WERE DECONTAMINATED, AND RETURNED TO THE MANUFACTURER WHERE ANALYSIS INDICATED THAT THE SENSING LEAD HAD SHIFTED POSITION THRU THE MOVEABLE LEAD ANCHOR. THIS REDUCED THE SIZE OF THE LOOP BETWEEN THE TWO ANCHORS WHICH IS REQUIRED FOR STRAIN RELIEF. THE PATIENT WAS NOT INJURED AS A RESULT OF THIS INCIDENT, BUT IF THE EVENT WERE TO RECUR IT IS POSSIBLE THAT IT COULD LEAD TO INAPPROPRIATE STIMULATION THEREFORE THE MANUFACTURER IS FILING THIS REPORT.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 5420030 ↗
• InjuryFeb 9, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PNEUMOTHORAX OCCURRED ASSOCIATED WITH PLACEMENT OF SENSOR LEAD. CHEST TUBE PLACED TO TREAT PNEUMOTHORAX. REVISION PROCEDURE CONDUCTED (B)(6) 2015 TO REPOSITION SENSOR LEAD DISTAL PORTION. PATIENT TREATED WITH ANTIBIOTIC PROPHYLAXIS TO MINIMIZE RISK OF DEVICE-RELATED INFECTION WITH OR WITHOUT CONCOMITANT INVOLVEMENT OF CHEST TUBE.

  Patient problems: Pneumothorax

  MAUDE report 5419536 ↗

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