The Vest APX System M08368Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00887761967366), received between Mar 6, 2025 and Apr 24, 2026 — classified as 1 death, 13 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED OXYGEN DESATURATION ONE DAY AFTER THE INITIAL SET UP OF THE VEST APX DEVICE. PATIENT HAS A TRACHEOSTOMY AND TYPICALLY WEARS A TRACH COLLAR ON ROOM AIR, WITH A BASELINE OXYGEN SATURATION OF 95-99%. ON MARCH PATIENT¿S OXYGEN SATURATION DROPPED TO THE HIGH 80¿S WITH NO MEDICAL INTERVENTION REQUIRED. ONE DAY LATER, THE PATIENT¿S OXYGEN SATURATION DROPPED TO 73%, PATIENTS¿ FINGERS AND NAILS TURNED PURPLE AND PATIENT WAS PLACED ON 3L OF OXYGEN, TAKING ONE HOUR TO RETURN TO BASELINE. CURRENTLY PATIENT SATURATION REMAINS IN THE LOW 90'S. PATIENT BELIEVES THAT THIS IS CAUSED BY MUCUS BLOCKING THE AIRWAY, CUSTOMER CONFIRMED PATIENT HAS SUCTION EQUIPMENT THAT CAN BE USE. THE RESPIRATORY CLINICIAN PROVIDED EDUCATION INCLUDING THE IMPORTANCE OF EFFECTIVE AIRWAY CLEARANCE ALONG WITH THE RISK OF MEDICAL EMERGENCIES IF MUCUS CANNOT BE CLEARED. THE DEVICE INSTRUCTIONS FOR USE WARNS USERS: ¿PATIENTS THAT MAY HAVE DIFFICULTY CLEARING SECRETIONS FROM THE UPPER AIRWAY MAY REQUIRE SPECIALIZED THERAPY IN ADDITION THE VEST APX SYSTEM THERAPY. PLEASE CONSULT YOUR PHYSICIAN TO DETERMINE IF ADDITIONAL THERAPY IS APPROPRIATE.¿ THERE WAS NO ALLEGATION OF A DEVICE MA

  Patient problems: Low Oxygen Saturation

  MAUDE report 24985492 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT EXPERIENCED SEVERE WORSENING BACK PAIN WHEN USING THE VEST APX SYSTEM. APPROXIMATELY FOUR MONTHS AGO, THE PATIENT LAST USED THE VEST DUE TO WORSENING BACK PAIN ¿TO THE POINT THAT THEY WERE UNABLE TO SIT UP.¿ THE PATIENT CONSULTED THEIR HEALTHCARE PROVIDER AND AN MRI WAS ORDERED. ACCORDING TO THE PATIENT, ONE DISC IS COMPROMISED ON THE LEFT SIDE, AND ANOTHER DISC SHOWS A 5 MM ROTATIONAL DISPLACEMENT THAT THEY DESCRIBED AS ¿ROTATED OUT OF POSITION AND MOVED BACKWARD.¿ THE PATIENT IS UNSURE HOW THIS OCCURRED AND STATED THAT VEST THERAPY ¿MADE IT WORSE.¿ THE PATIENT DECLINED REQUIRING MEDICATION AND REPORTED SEEING A PHYSICAL THERAPIST AND A CHIROPRACTOR FOR SUPPORT. THERE WAS NO REPORT OF DEVICE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

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

  MAUDE report 24537239 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT SUSTAINED AN EYE INJURY COINCIDENT WITH USE OF THE VEST APX SYSTEM. THE PATIENT HAD LEFT EYE CATARACT SURGERY IN THE SUMMER OF 2025 WHICH TOOK A PROLONGED TIME TO RECOVER DUE TO DELAYED HEALING. THE PATIENT SUSPENDED USE OF THE VEST FOR APPROXIMATELY TWO WEEKS AFTER SURGERY. THE PATIENT REPORTEDLY DID NOT CONSULT THEIR EYE DOCTOR/SURGEON REGARDING USE OF THE VEST DEVICE PRIOR TO OR FOLLOWING THE CATARACT SURGERY. THE PATIENT RESUMED USE OF THE VEST SIXTEEN DAYS POST OPERATIVELY. APPROXIMATELY TWO DAYS AFTER RESUMING USE OF THE VEST THE PATIENT DEVELOPED A ¿FLOATER¿ IN THEIR LEFT EYE. AFTER AN UNSPECIFIED AMOUNT OF TIME, THE PATIENT FOLLOWED UP WITH THEIR EYE DOCTOR WHO INFORMED THEM THAT THEY HAD A ¿RUPTURED WATER SAC WHICH CAUSES A PERMANENT FLOATER¿. THE PATIENT REPORTED ¿IF I TURN CERTAIN DIRECTIONS, I CAN SEE THE WATER SAC¿. THERE WAS NO REPORT OF A DEVICE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Vitreous Detachment

  MAUDE report 24474329 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT DEVELOPED ATRIAL FIBRILLATION (A-FIB) AFTER USING THE VEST APX SYSTEM. THE PATIENT RECEIVED THE VEST APPROXIMATELY THREE WEEKS AGO AND USED IT REGULARLY DURING THAT TIME. SINCE THEN, THE PATIENT HAS EXPERIENCED BACK PAIN. FOURTEEN DAYS PRIOR TO THIS REPORT, THE PATIENT WENT TO THE HOSPITAL. ALLEGEDLY THE PATIENT¿S BACK PAIN WAS ¿SO SEVERE THAT IT PLACED THEIR HEART INTO A-FIB.¿ REPORTEDLY THE PATIENT WAS IN THE EMERGENCY DEPARTMENT FOR TWO DAYS. THE PATIENT FELT THEY WERE NOT RECEIVING ADEQUATE CARE AND THREE DAYS LATER WAS ADMITTED TO A DIFFERENT HOSPITAL. IN THIS HOSPITAL THE PATIENT WAS TREATED FOR PAIN AND A-FIB. THE PATIENT REPORTED THREE OF THEIR VERTEBRAE HAD SHIFTED IN THE CERVICAL AREA OF THEIR SPINE, AND THEIR MEDICAL TEAM ADVISED THAT THE A-FIB WAS A RESULT OF THEIR PAIN LEVEL FROM THE SHIFTED VERTEBRAE. THE PATIENT STATED THAT THEY HAD A CARDIAC CATHETERIZATION AND ECHO TESTS DONE, AND NO ABNORMALITIES WERE FOUND. FIVE DAYS AFTER ADMISSION, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH A NECK BRACE AND TRACTION THERAPY. THE PATIENT IS NOW WEARING A NECK BRACE, AND THE PAIN HAS SUBSIDED. REPORTEDLY THE PATIENT WILL START TRACTION THERAPY ¿SO

  Patient problems: Atrial Fibrillation

  MAUDE report 24337089 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A CUSTOMER DEVELOPED AN INFECTION WHILE USING A THE VEST APX. THE CUSTOMER CONTACTED BAXTER TO REPORT THEY BECAME ¿VERY SICK¿ AND WASN¿T SURE ¿IF THE VEST CAUSED IT OR NOT.¿ THE CUSTOMER MADE AN APPOINTMENT WITH THEIR HEALTH CARE PROVIDER; HOWEVER, THE CUSTOMER COULD NOT GET THERE IN TIME. THEREFORE, THE CUSTOMER VISITED THE URGENT CARE INSTEAD. AT THE URGENT CARE THE CUSTOMER WAS GIVEN PREDNISONE, ¿AN ANTIBIOTIC TO BREAK UP THE CONGESTION¿ AND PROMETHAZINE. ADDITIONALLY, THERE WAS NO REPORT OF DEVICE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Respiratory Tract Infection

  MAUDE report 24201499 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PEDIATRIC PATIENT REQUIRED A GASTROSTOMY TUBE (G-TUBE) REPLACEMENT DUE TO THE THE VEST APX SYSTEM. THE PATIENT¿S PARENTAL CAREGIVER (PC) REPORTED ¿THAT THE VEST SITS APPROXIMATELY THREE INCHES ABOVE THE G-TUBE AND DOES NOT COVER IT¿; THEREFORE, ¿EVERY TIME THE VEST IS USED, THE G-TUBE BECOMES LOOSE.¿ ON THE DAY OF THE EVENT THE G-TUBE FELL OUT AND THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM FOR G-TUBE REINSERTION. THE PATIENT WAS TAKEN TO THE GASTROENTEROLOGY APPOINTMENT THE FOLLOWING DAY FOR POTENTIAL G-TUBE REPLACEMENT OR A PROCEDURE FOR A NEW TUBE. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

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

  MAUDE report 24133067 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT¿S OXYGEN DESATURATED WHEN USING THE VEST APX SYSTEM. DURING INITIAL SET UP WITH THE RESPIRATORY TRAINER, THE PATIENT¿S OXYGEN SATURATION DECREASED TO 86%. THE PATIENT USES CONTINUOUS OXYGEN AT 3 TO 3.5L. THE PATIENT¿S OXYGEN DESATURATION LASTED APPROXIMATELY ONE TO TWO MINUTES. THE OXYGEN WAS INCREASED TO 5L AND THE PATIENT RETURNED TO ¿NORMAL RANGE¿ (NOT FURTHER SPECIFIED). THE PATIENT REACHED OUT TO THEIR HEALTHCARE TEAM AND WAS ADVISED TO RESUME USAGE OF THE VEST DEVICE AND TO DISCONTINUE THERAPY IMMEDIATELY IF THEIR OXYGEN SATURATION BECAME LESS THAN 90%. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION, AND THE DEVICE REMAINED WITH THE PATIENT FOR CONTINUED USE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24063619 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT VEST APX SYSTEM SUSTAINED AN INJURY. IN 2021, THE PATIENT UNDERWENT BILATERAL BREAST RECONSTRUCTIVE EXPANDER REMOVAL AND IMPLANT REPLACEMENT WITH BREAST IMPLANTS AND A TISSUE GRAFT INSERTION. APPROXIMATELY, ELEVEN MONTHS AGO (FROM THE DATE OF THIS REPORT) THE PATIENT PERFORMED THERAPY FOR THE FIRST TIME USING THE VEST APX SYSTEM. THE PATIENT COMPLETED A TWENTY-MINUTE SESSION USING THE LOWEST PRESCRIBED SETTINGS (9HZ, INTENSITY 4). POST THERAPY THE PATIENT COMPLAINED OF ¿PAIN AND A PULLING¿ SENSATION AT THE AREA OF THE LEFT BREAST/BREAST IMPLANT. AT AN UNKNOWN TIME FOLLOWING THE EVENT, THE PATIENT SAW THEIR PLASTIC SURGEON. AN ULTRASOUND WAS PERFORMED THAT CONFIRMED THAT THE PATIENT¿S BREAST IMPLANTS WERE/REMAINED INTACT. AT A LATER DATE, THE SURGEON ALLEGEDLY REACHED OUT TO THE PATIENT TO INFORM THEM THAT THE ¿AGGRESSIVE VIBRATION¿ (FROM THE VEST) HAD LOOSENED SOME SCAR TISSUE. THE PATIENT CONFIRMED THAT NO TREATMENT WAS PROVIDED, AND NO MEDICAL PROCEDURES WERE PERFORMED. THE PATIENT REPORTED THEY ARE ¿STARTING TO FEEL BETTER.¿ THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Physical Asymmetry

  MAUDE report 23302611 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT¿S GASTROSTOMY TUBE (G-TUBE) ¿FELL OUT¿ AFTER REMOVING THE VEST APX SYSTEM. AFTER THE VEST AND THE PATIENT¿S CLOTHES WERE REMOVED, THE G-TUBE ¿FEEL ONTO THE FLOOR.¿ THE PATIENT WENT TO THE EMERGENCY ROOM WHERE THEY RECEIVED UNSPECIFIED ¿TREATMENT.¿ THE FOLLOWING DAY THE PATIENT UNDERWENT AN ¿OUTPATIENT PROCEDURE¿ TO HAVE THE G-TUBE REINSERTED. THE PATIENT WAS DISCHARGED THAT SAME DAY. THERE WAS NO REPORT OF A DEVICE MALFUNCTION. THE VEST WILL REMAIN WITH THE PATIENT AS THEY PLAN TO RETURN TO USING THE VEST. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Unspecified Gastrointestinal Problem

  MAUDE report 22983910 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT SUSTAINED COMPRESSION ULCERS DURING USE OF A VEST APX SYSTEM. THE PATIENT REPORTEDLY INCURRED COMPRESSION ULCERS IN THEIR STOMACH AND THEY BECAME INFECTED. THE PATIENT WAS SEEN BY THEIR HEALTHCARE PROVIDER (HCP) AND WAS PRESCRIBED UNSPECIFIED ANTIBIOTICS. THE HCP ADVISED THE PATIENT TO HOLD OFF ON USE OF THE DEVICE; HOWEVER, THE PATIENT HAS CHOSEN TO DISCONTINUE THE VEST. ADDITIONALLY, THERE WAS NO REPORT OF A DEVICE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Skin Erosion

  MAUDE report 22806672 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UTILIZING A VEST APX SYSTEM SUSTAINED A SHIFT IN THEIR PACEMAKER DEVICE. REPORTEDLY THE VEST SHOOK THE PATIENT ¿SO BAD¿ THAT IT MOVED THE PATIENT¿S IMPLANTED, UNSTITCHED PACEMAKER DEVICE TWO INCHES TO THE LEFT. THIS CAUSED THE PATIENT¿S HEART RATE TO LOWER (RATE UNKNOWN). THE PATIENT REQUIRED SURGERY TO REPAIR THE PACEMAKER. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION, AND THE DEVICE IS NOT BEING RETURNED. THE PATIENT¿S HEALTHCARE PROVIDER ADVISED THE PATIENT TO RESUME THERAPY 6-WEEKS POST RECENT PROCEDURE. AN IN-HOME PATIENT FOLLOW-UP VISIT IS PLANNED UPON THE PATIENT¿S CLEARANCE TO RESUME THERAPY, FOR CONFIRMATION OF DEVICE SETTING, AND GARMENT FIT. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Twiddlers Syndrome

  MAUDE report 22675379 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT¿S COMPRESSION FRACTURE WORSENED WHEN UTILIZING A VEST APX SYSTEM. THE PATIENT SUSTAINED A T12 COMPRESSION FRACTURE FROM AN UNKNOWN CAUSE PRIOR TO USE OF THE VEST APX SYSTEM. AFTER AN UNKNOWN AMOUNT OF TIME POST FRACTURE, THE PATIENT WAS PRESCRIBED THE VEST. REPORTEDLY AFTER USING THE VEST ¿FOR A WHILE¿ THE PATIENT¿S BACK WAS ¿GETTING WORSE¿ AND THEIR PHYSICIAN RECOMMENDED A REPEAT X-RAY. THE X-RAY SHOWED THE COMPRESSION FRACTURE WAS ¿GETTING WORSE.¿ NO MEDICAL INTERVENTION WAS REQUIRED AND NO REPORT OF A DEVICE MALFUNCTION. THE PATIENT WAS TO FOLLOW UP WITH THEIR PULMONOLOGIST FOR FURTHER INSTRUCTIONS ON USE OF THE DEVICE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

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

  MAUDE report 22379365 ↗
• DeathMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATED THE PATIENT EXPIRED THE DAY AFTER USING THE VEST APX SYSTEM. IT WAS REPORTED THE PATIENT PERFORMED VEST THERAPY AND THE THERAPY DISLODGED THE MUCUS INTO THE PATIENT¿S BRONCHIAL TUBES WHICH THE REPORTER STATED CAUSED THE PATIENT TO HAVE PROBLEMS WITH BREATHING. IT WAS REPORTED THE PATIENT¿S DIFFICULTY BREATHING CONTINUED THROUGHOUT THE NEXT DAY. EMERGENCY SERVICES REPORTEDLY WERE CALLED; THE PATIENT REPORTEDLY WAS TRANSPORTED TO THE HOSPITAL AND THE REPORTER STATED THAT LATER THAT SAME DAY THE PATIENT DIED. NO FURTHER MEDICAL TREATMENT OR INTERVENTIONS WERE REPORTED. THERE WAS NO REPORT OF A DEVICE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Cardiac Arrest; Dyspnea

  MAUDE report 21986900 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ¿SUDDEN VISION DISTORTION¿ WHILE USING A VEST APX SYSTEM. THE PATIENT RELAYED THAT WHEN THEY USE THE VEST, ¿THE DEVICE SHAKES SO MUCH IT SHAKES THEIR EYES¿. THE PATIENT ALSO DESCRIBED THE DISTORTION AS HAVING AN ¿INDENTATION ON THE LEFT SIDE¿ WHEN LOOKING AT SOMETHING ROUND, AND WHEN LOOKING AT THE NEWSPAPER IT ¿SEEMS TO HAVE HOLES IN IT.¿ THE PATIENT ALSO REPORTED THE DISTORTION HAD NOT RESOLVED. THE PATIENT NOTIFIED THEIR ¿RETINA SPECIALIST¿ AND WAS ADVISED THEY ¿THIN RETINAS." THE SPECIALIST ADVISED THE PATIENT TO DISCONTINUE USE OF THE VEST DEVICE. THE PATIENT ALSO NOTIFIED THEIR PULMONOLOGIST, WHO ADVISED THE PATIENT TO CONTINUE USE, BUT LOWER DEVICE SETTINGS. THERE WAS NO REPORT OF A DEVICE MALFUNCTION. THE PATIENT HAS CHOSEN TO DISCONTINUE USE OF THE DEVICE, AND THE DEVICE WILL BE RETURNED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Visual Disturbances

  MAUDE report 21541996 ↗