Smartvest Clearway Air Pulse GeneratorRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI B102125003S0100), received between May 2, 2024 and Apr 30, 2026 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED USING SMARTVEST 2X DAILY FOR 3-4 DAYS AT 6-14 HZ AND 20-30% PRESSURE FOR 15 MINUTES. PATIENT REPORTED ONSET OF BACK PAIN, DISCONTINUED USE, AND LATER REQUIRED ER EVALUATION WITH 1-DAY HOSPITALIZATION (DATES NOT PROVIDED). CT IMAGING IDENTIFIED MULTIPLE SPINAL COMPRESSION FRACTURES. PATIENT WAS TREATED WITH A BACK BRACE AND PAIN MEDICATION AND LATER ADVISED BY A SPINE SPECIALIST TO DISCONTINUE USE; NO CAUSALITY DETERMINATION WAS PROVIDED. PATIENT HAS A HISTORY OF OSTEOPOROSIS, A KNOWN RISK FACTOR FOR COMPRESSION FRACTURES. NO DEVICE MALFUNCTION WAS REPORTED. DEVICE NOT AVAILABLE FOR EVALUATION AS THE PATIENT DECLINED RETURN. CAUSALITY HAS NOT BEEN ESTABLISHED.

  Patient problems: Back pain

  MAUDE report 25050057 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TRAINED ON THE SMARTVEST ON 12/8, USING SETTINGS 8-9-10 HZ 25-20-30% FOR 5 MIN EACH ON THERAPY1. SHE USED THE SMARTVEST FOR ABOUT A MONTH. SHE STARTED HAVING HEADACHES AND BACK ISSUES, SHE BEGAN TO EXPERIENCE MOBILITY ISSUES AND STARTED HAVING DIFFICULTY WALKING. SHE WENT TO A CHIROPRACTOR WHO STATED HER BACK WAS OUT OF ALIGNMENT LIKELY DUE TO THE SMARTVEST. AFTER SEVERAL WEEKS OF SEEING THE CHIROPRACTOR SHE RETURNED TO BASELINE WITH NO FURTHER ISSUES.

  Patient problems: Back pain

  MAUDE report 24682603 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED NOTICING AN ELEVATED HEART RATE AFTER USING THE SMARTVEST DEVICE. SHE STATED HER TYPICAL RESTING HEART RATE RANGES FROM 60-80 BPM AND THAT SHE OBSERVED READINGS OF 118-133 BPM AT REST. SHE DID NOT REPORT CHEST PAIN, SHORTNESS OF BREATH, OR ADDITIONAL SYMPTOMS. PER THE PATIENT'S DAUGHTER, THE CARDIOLOGIST WAS NOT CONCERNED WITH CONTINUED SMARTVEST USE AS LONG AS THE PATIENT'S HEART RATE RETURNED TOWARD HER USUAL BASELINE. THE ELECTROMED RESPIRATORY THERAPIST ADVISED TEMPORARILY REDUCING THERAPY SETTINGS TO ALLOW THE PATIENT TO ACCLIMATE. THE PATIENT LATER FOLLOWED UP WITH HER CARDIOLOGIST ON (B)(6) 2025 AND WAS NOTED TO BE EXPERIENCING ATRIAL FIBRILLATION/ATRIAL FLUTTER WITH LOW BLOOD PRESSURE. AN EKG RECORDED A HEART RATE OF APPROXIMATELY 130 BPM. ELECTROMED WAS UNABLE TO OBTAIN FURTHER CLINICAL INFORMATION TO DETERMINE WHETHER THE REPORTED CARDIAC FINDINGS WERE RELATED TO SMARTVEST USE.

  Patient problems: Atrial Fibrillation

  MAUDE report 23771789 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THERAPY, PATIENT EXPERIENCED DIZZINESS AND THERAPY WAS STOPPED. KARDIAMOBILE WAS UTILIZED AND DETECTED THE PATIENT HAD ATRIAL FIBRILLATION WITH A HEART RATE OF 141. THE SYMPTOMS HAD RESOLVED ONCE THERAPY WAS STOPPED.THE PATIENT WAS ADVISED TO STOP THERAPY AND SPEAK WITH THE CARDIOLOGIST PRIOR TO CONTINUING THERAPY.

  Patient problems: Atrial Fibrillation

  MAUDE report 22738852 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT TRAINED TO MINIMAL MODE AT 5 HZ/10 % FOR 5 MIN WITH A GRADUAL "MINIMAL ROADMAP" RAMP. PATIENT BYPASSED THE RECOMMENDED SETTINGS DURING TRAINING AND SET THERAPY TO 8HZ/15% FOR 15 MINS. PATIENT REPORTED THE NEXT DAY SHE EXPERIENCED STROKE-LIKE SYMPTOMS, WAS TRANSPORTED TO THE HOSPITAL, AND WAS DIAGNOSED WITH A TRANSIENT ISCHEMIC ATTACK (TIA). SHE WAS DISCHARGED AFTER A FEW DAYS AND RESUMED NORMAL ACTIVITIES. PATIENT DID NOT WANT TO RETURN DEVICE AND REQUESTED A SMALLER VEST. PATIENT WAS INFORMED TO FOLLOW UP WITH HER MEDICAL DOCTOR PRIOR TO CONTINUING THERAPY.

  Patient problems: Transient Ischemic Attack

  MAUDE report 22384897 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT, AN 85-YEAR-OLD WITH SEVERAL PRE-EXISTING LUNG CONDITIONS INCLUDING BRONCHIECTASIS, BRONCHIOLITIS, GRANULOMATOUS LUNG DISEASE, AND A RECENT PSEUDOMONAS LUNG INFECTION, WAS TRAINED TO USE THE SMARTVEST ON (B)(6) 2023. DURING THE TRAINING, LOWER THERAPEUTIC SETTINGS WERE EMPLOYED. THE PATIENT REPORTED USING THE VEST CONSISTENTLY FROM (B)(6) 2023, TO (B)(6) 2024, WITHOUT ANY ISSUES. A COMPLIANCE FOLLOW-UP VISIT ON DECEMBER 22, 2023, REVEALED NO PROBLEMS; HOWEVER, THE PATIENT EXPRESSED AN INTENTION TO RETURN THE DEVICE. THE PATIENT DECIDED TO RETURN THE SMARTVEST, STATING THAT FROM (B)(6) 2023, TO (B)(6) 2024, SHE USED SETTINGS THAT RANGED FROM 5 HZ AT 10% INTENSITY FOR 5 MINUTES TO 8 HZ AT 25% INTENSITY FOR 5 MINUTES. SHE REPORTED EXPERIENCING A LUNG COLLAPSE, WHICH SHE STATED HER DOCTOR FELT IT COULD BE DUE TO USING THE SMARTVEST AND TO RETURN THE DEVICE. DURING ELECTROMED'S FOLLOW UP TO THIS COMPLAINT, THE PATIENT'S DOCTOR STATED THE DEVICE WAS UNLIKELY THE CAUSE FOR THE PATIENT'S LUNG COLLAPSE. AN INSPECTION PERFORMED BY A ELECTROMED TECHNICIAN NOTED THAT THE DEVICE WAS FUNCTIONING AS DESIGNED, NO MALFUNCTION WAS OBSERVED. THERE WAS NO REPORT OF DEVICE MALFUNCTION AND N

  Patient problems: Pneumothorax

  MAUDE report 19229502 ↗