inCourage® ICS-1M-US-A (UDI 00841561102785)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00841561102785), received between Jul 10, 2018 and Sep 4, 2026 — classified as 20 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 reports).

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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• OtherSep 4, 2026Insufficient Device Problem Information

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50614893 ↗
• InjuryJun 30, 2026Insufficient Device Problem Information

  THE PATIENT'S DAUGHTER SAID THE PATIENT HAS BEEN IN THE HOSPITAL WITH PNEUMONIA AND A BROKEN RIB. SUSPECTS THAT IT IS FROM THE DEVICE.

  Patient problems: Bone Fracture(s)

  MAUDE report 25665421 ↗
• InjuryJun 17, 2026Insufficient Device Problem Information

  OUTCOMES REPRESENTATIVE SPOKE WITH THE PATIENT FOR 12-MONTH OUTCOMES WHO SAID HE RETURNED THE THERAPY TO THE VA LAST OCTOBER AS IT BROKE VERTEBRA IN HIS BACK. THE PATIENT DID NOT KNOW THE NAME OF THE MEDICAL DOCTOR WHO TREATED HIM, AND SAID HE HAS RECOVERED AND IS DOING OKAY.

  Patient problems: Bone Fracture(s)

  MAUDE report 25537183 ↗
• MalfunctionMar 30, 2026Electrical /Electronic Property Problem

  THE DEVICE IS NOT TURNING ON, SPARKED WHEN THE PATIENT TRIED TO OPERATE. RETURNING THE DEVICE AND POWER CORD FOR QUALITY INSPECTION, NO PT HARM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24713718 ↗
• MalfunctionMar 19, 2026Electrical /Electronic Property Problem; Grounding Malfunction

  THE PATIENT STATES DEVICE HAS BURNED TERMINALS WHERE CORD PLUGS IN THE BACK.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24637711 ↗
• InjuryOct 28, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  RESPIRTECH RECEIVED A REPORT FROM THE PATIENT'S MOTHER STATING THAT THE DEVICE "BURST" AND THAT A FIRE OCCURRED AT THE RESIDENCE. AN INVESTIGATION WAS CONDUCTED BY THE LOCAL FIRE DEPARTMENT. ACCORDING TO THE OFFICIAL FIRE INVESTIGATION REPORT, THE FIRE ORIGINATED ON OR NEAR THE BED ON THE EAST WALL OF THE TRAILER. THE INVESTIGATOR WAS UNABLE TO RULE OUT EITHER THE ELECTRICAL CORD TO THE DEVICE TO THE INCOURAGE DEVICE OR A CANDLE LOCATED ON THE DESK AS POTENTIAL SOURCES. BASED ON THE EVIDENCE AND SCENE CONDITIONS, THE FIRE WAS CLASSIFIED AS ACCIDENTAL. AT THIS TIME, THERE IS NO CONCLUSIVE EVIDENCE IDENTIFYING THE DEVICE AS THE DEFINITIVE CAUSE OF THE FIRE. RESPIRTECH WILL CONTINUE TO MONITOR FOR ANY ADDITIONAL INFORMATION THAT MAY BECOME AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23404915 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT STATED: I USE NEBULIZER AT THE SAME TIME AS THE VEST. I CANNOT TELL WHICH ONE HELPS ME MORE. I HAVE NOT USED THE VEST FOR ABOUT A WEEK DUE TO RIB SEPARATION. I SHOULD START BACK IN 2 WEEKS. I WAS USING 1X PER DAY FOR 30 MINUTES AT 55% PRESSURE. OUTCOMES SPOKE WITH THE PATIENT'S DAUGHTER WHO ADVISED THAT THE PATIENT WILL NOT USE THERAPY AS HE SAID IT IS NOT BENEFITING HIM AND FEELS IT CAUSED HIS RIB PAIN. OS ADVISED ABOUT REDUCING TIME AND PRESSURE, BUT SHE SAID THE PATIENT WAS FIRM IN THE DECISION TO RETURN AND THAT HIS HCT SAID HE COULD DISCONTINUE THERAPY. THE DEVICE WILL BE RETURNED.

  Patient problems: Bone Fracture(s)

  MAUDE report 20272855 ↗
• InjuryAug 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, PT REPORTED SHE WAS HAVING DISCOMFORT IN BACK WHILE DOING THERAPY. ON 08/23 PT REPORTED SHE HAS COMPRESSION FRACTURES IN BACK CLINICAL RESOURCE SPECIALIST REVIEWED THE PATIENT'S MEDICAL RECORDS, THE PATIENT HAS A HISTORY OF COMPRESSION FRACTURES. THE PATIENT IS RETURNING THE DEVICE, SHE CANNOT TOLERATE THERAPY.

  Patient problems: Bone Fracture(s)

  MAUDE report 20100496 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN INCOURAGE DEVICE CAUSED THE PATIENT TO HAVE PAIN IN HER RIGHT SIDE. THERE WAS NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

  Patient problems: Pain

  MAUDE report 15879480 ↗
• InjuryApr 13, 2022Contamination; Adverse Event Without Identified Device or Use Problem; Contamination; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN INCOURAGE DEVICE CAUSED A PATIENT TO COUGH UP BLOOD DURING THERAPY. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. THE PATIENT DISCONTINUED USE OF THE DEVICE. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Cough

  MAUDE report 14103307 ↗
• InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT FRACTURED RIBS 5 AND 6 ON BOTH SIDES DUE TO COUGHING HARD AND THE INCOURAGE DEVICE BEING TOO TIGHT. THE MEDICAL INTERVENTION WAS NOT SPECIFIED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Bone Fracture(s)

  MAUDE report 13949621 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN INCOURAGE DEVICE CAUSED THE PATIENT'S DEFIBRILLATOR TO DISCHARGE WHILE USING THE DEVICE. THERE WAS NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER FOUND NO ISSUES WITH THE DEVICE. THE MANUFACTURER FOUND THE DEVICE TO BE CONTAMINATED WITH A LIQUID. THE DEVICE WAS SCRAPPED BY THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908403 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN INCOURAGE DEVICE CAUSED COSTOCHONDRITIS WHICH RESULTED IN BRUISING OF SKIN AND UNABLE TO TAKE A DEEP BREATH. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Easy Bruising

  MAUDE report 12519986 ↗
• InjuryMay 25, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING VEST THERAPY WITH AN INCOURAGE DEVICE CAUSED A HEART CONDITION. THE PATIENT IS CURRENTLY WEARING A HEART MONITOR AND CONTINUES TO RECEIVE VEST THERAPY. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 11878266 ↗
• InjuryMay 19, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ENCOURAGE DEVICE CAUSED BROKEN RIBS. THERE WAS NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Bone Fracture(s)

  MAUDE report 11849926 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN INCOURAGE DEVICE CAUSED DEBILITATING CRAMPING. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 11706015 ↗
• InjuryApr 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN INCOURAGE DEVICE CAUSED A HERNIA. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Hernia

  MAUDE report 11671692 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN INCOURAGE VEST THERAPY DEVICE CAUSED A BROKEN RIB. THE PATIENT DISCONTINUED VEST THERAPY. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Bone Fracture(s)

  MAUDE report 11598892 ↗
• InjuryFeb 25, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING VEST THERAPY WITH AN INCOURAGE DEVICE CAUSED A HEART CONDITION. THE PATIENT IS CURRENTLY WEARING A HEART MONITOR AND CONTINUES TO RECEIVE VEST THERAPY. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 11378092 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN INCOURAGE DEVICE CAUSED A COMPRESSED SPINE FRACTURE. THE PATIENT WAS INITIALLY HOSPITALIZED FOR THREE DAYS AND THEN TRANSFERRED TO REHABILITATION. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Vertebral Fracture

  MAUDE report 11281109 ↗
• InjuryAug 27, 2020Electromagnetic Interference; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN INCOURAGE VEST THERAPY INTERFERED WITH A PATIENT'S PACEMAKER. THE ISSUE WAS NOTED BY THE PATIENT'S CARDIOLOGIST. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Patient Problem/Medical Problem

  MAUDE report 10460886 ↗
• InjuryOct 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD BEEN USING VEST THERAPY SUCCESSFULLY FOR 6 MONTHS, THEN WAS HOSPITALIZED FOR AN UNRELATED CONDITION. AFTER BEING DISCHARGED, PATIENT RESUMED VEST THERAPY AND AFTER THREE SESSIONS, PATIENT DEVELOPED SHORTNESS OF BREATH. PATIENT WAS TAKEN TO THE ER AND FOUND TO HAVE A PNEUMOTHORAX ON THE LEFT AND WAS ADMITTED. SPOUSE STATES THAT HOSPITAL PHYSICIANS DO NOT KNOW CAUSE OF PNEUMOTHORAX. FOLLOWED UP WITH PATIENT'S PULMONOLOGIST WHO SAID THAT AT THIS TIME THEY FEEL THE PNEUMOTHORAX IS UNRELATED TO VEST USE, HOWEVER THEY CANNOT MAKE AN ABSOLUTE DETERMINATION. RESULTS OF MANUFACTURER TESTING OF RETURNED DEVICE: THE DEVICE WAS FOUND TO BE OPERATING NORMALLY WITHIN DEFINED SPECIFICATIONS.

  Patient problems: Pneumothorax

  MAUDE report 8019124 ↗
• InjuryJul 10, 2018Pressure Problem; Pressure Problem

  PATIENT REPORTED BREAST PAIN, WHICH WAS DIAGNOSED AS MASTITIS. ATTENDING PHYSICIAN COULD NOT DETERMINE IF VEST THERAPY WAS THE CAUSE OF THE CONDITION. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION OR COMPLETE AN EVALUATION OF THE DEVICE. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7673238 ↗