The Vest®System P105Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00887761997776), received between Feb 13, 2023 and Sep 29, 2026 — classified as 11 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (16 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940039 ↗
• MalfunctionSep 25, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902040 ↗
• MalfunctionJun 8, 2026Material Split, Cut or Torn

  BAXTER RECEIVED A REPORT THAT THE VEST SYSTEM HAD POWER CORD DAMAGED WITH COPPER WIRE EXPOSED. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25438179 ↗
• MalfunctionApr 23, 2026Material Split, Cut or Torn

  BAXTER RECEIVED A REPORT THAT VEST MODEL 105 HAD POWER CORD DAMAGED WITH COPPER WIRE EXPOSED. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24974877 ↗
• InjuryApr 21, 2026Appropriate Device Problem Term/Code Not Available

  IT IS REPORTED THE PATIENT HAS RETAINED SECRETIONS AND IT IS NOTED THAT THE PATIENT IS SCHEDULED FOR A BRONCHOSCOPE DILATION/CLEANOUT PROCEDURE AS A RESULT OF THE PATIENT¿S LACK OF ACCESS TO VEST THERAPY DURING THE DELAY IN DEVICE REPLACEMENT. CUSTOMER INITIALLY CONTACTED BAXTER RESPIRATORY CUSTOMER SUPPORT ON FOURY NINE DAYS FROM THIS REPORT TO REQUEST A REPLACEMENT OF THE VEST AFTER REPORTING THAT WATER WAS PRESENT IN THE DEVICE TUBING. AT THE TIME OF THIS INITIAL CONTACT, THERE WAS NO ALLEGATION OF PATIENT INJURY. BAXTER RESPIRATORY CUSTOMER SUPPORT ADVISED THE PATIENT NOT TO USE THE DEVICE DUE TO THE PRESENCE OF WATER. AN EXCHANGE OF THE VEST DEVICE WAS INITIATED THE NEXT DAY, INVOLVING BAXTER AND THE PATIENT¿S PRESCRIBING PHYSICIAN; HOWEVER, THE EXCHANGE COULD NOT BE COMPLETED DUE TO THE PATIENT¿S INSURANCE AND/OR FINANCIAL OBLIGATIONS. THE CUSTOMER REPORTED CONCERNS THAT THE PATIENT SUBSEQUENTLY DEVELOPED INCREASED RETAINED RESPIRATORY SECRETIONS AND IS SCHEDULED TO UNDERGO A BRONCHOSCOPY PROCEDURE FOR AIRWAY DILATION AND SECRETION CLEARANCE. THE CUSTOMER BELIEVES THIS CONDITION RESULTED FROM THE PATIENT¿S LACK OF ACCESS TO VEST THERAPY DURING THE DELAY IN DEVICE REPLACEMENT.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 24946147 ↗
• MalfunctionMar 4, 2026Material Split, Cut or Torn

  ON 06-FEB-2026, A NURSE CONTACTED TECHNICAL SERVICE TO REPORT THAT VEST, MODEL 105 BLE (PRODUCT CODE P105000BT, SERIAL NUMBER (B)(6)), HAD POWER CORD DAMAGED WITH COPPER WIRES EXPOSED. THIS OCCURRED AT HOME DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24513928 ↗
• MalfunctionDec 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 15-DEC-2025, A CUSTOMER CONTACTED TECHNICAL SERVICE TO REPORT THAT VEST, MODEL 105 BLE (PRODUCT CODE P105000BT, SERIAL NUMBER (B)(6), HAD POWER CORD DAMAGED WITH COPPER WIRES EXPOSED. THIS OCCURRED AT HOME DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23855204 ↗
• MalfunctionDec 17, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2025, A PATIENT CONTACTED TECHNICAL SERVICE TO REPORT THAT VEST MODEL 105 (PRODUCT CODE P105, SERIAL NUMBER (B)(6)), HAD POWER CORD DAMAGED WITH COPPER WIRES EXPOSED. THIS OCCURRED AT HOME DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827939 ↗
• MalfunctionNov 3, 2025Sparking; Material Split, Cut or Torn; Sparking; Material Split, Cut or Torn

  BAXTER RECEIVED A REPORT STATING THAT VEST, MODEL 105 POWER CORD WAS SHORTING WITH EXPOSED COPPER WIRES. THIS OCCURRED AT HOME DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23456431 ↗
• MalfunctionOct 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 30-SEP-2025, A CUSTOMER CONTACTED TECHNICAL SERVICE TO REPORT THAT VEST MODEL 105 SERVICED (PRODUCT CODE PR105, SERIAL NUMBER (B)(6)), HAD POWER CORD DAMAGED WITH COPPER WIRES EXPOSED. THIS OCCURRED AT HOME DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383326 ↗
• MalfunctionOct 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  BAXTER RECEIVED A REPORT STATING THAT VEST MODEL 105 POWER CORD HAD DAMAGE WITH EXPOSED COPPER WIRES. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280521 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT SUSTAINED A COLLAPSED LUNG COINCIDENT WITH A VEST SYSTEM. WHILE HOSPITALIZED, THE PATIENT WAS RECOMMENDED TO TRY THE VEST AND WAS TRAINED ON THE DEVICE. THE VEST WAS SET AT 12HZ/4/20 MIN AND DISCHARGED HOME. THREE DAYS POST DISCHARGE THE PATIENT RETURNED TO THE HOSPITAL WITH A COLLAPSED LUNG. THE PATIENT WAS HOSPITALIZED FOR SEVENTEEN DAYS. INPATIENT MEDICAL TREATMENT WAS NOT REPORTED. THE PATIENT WAS DISCHARGED HOME WITH THE PLAN TO RETURN THE FOLLOWING DAY FOR A SURGICAL HERNIA MESH AND ¿FUSING THEIR LUNGS TO THE CHEST WALL TO HELP PREVENT FURTHER COLLAPSED LUNGS.¿ THE PATIENT WAS ADVISED NOT TO USE THE VEST MOVING FORWARD. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pneumothorax

  MAUDE report 22923953 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT SUSTAINED A COMPRESSION FRACTURE DURING USE OF A VOLARA VEST. APPROXIMATELY ONE AND A HALF YEARS AGO, THE PATIENT WAS ¿PUTTING A DISH IN THE DISHWASHER, HEARD A CRACK AND EXPERIENCED BACK PAIN.¿ THEY INITIALLY CONSULTED THEIR HEALTHCARE PROVIDER, AND A CORTISONE INJECTION WAS PROVIDED; ALONG WITH AN X-RAY. THE X-RAY RESULTS SHOWED NO INJURIES. THE PATIENT CONTINUED TO HAVE PAIN AND RETURNED TO THEIR DOCTOR THREE DAYS LATER. THE DOCTOR ORDERED AN MAGNETIC RESONANCE IMAGING (MRI), AND A COMPRESSION FRACTURE WAS IDENTIFIED. THE PATIENT WAS ADVISED TO TAKE PAIN RELIEF MEDICATION (NOT FURTHER SPECIFIED) AND WEAR A BRACE. AROUND THAT SAME TIME, THE PATIENT WAS HOSPITALIZED FOR AN UNRELATED ISSUE. DURING HOSPITALIZATION, THE PATIENT REQUIRED A COMPUTED TOMOGRAPHY SCAN (CT) AND THE RESULTS IDENTIFIED THREE COMPRESSION FRACTURES. THE PATIENT¿S PHYSICIAN STATED THE PATIENT¿S FOUR YEARS OF PREDNISONE USE AND THE VOLARA THERAPY CONTRIBUTED TO THE COMPRESSION FRACTURES. THE PATIENT HAS NOT USED THE VOLARA VEST SINCE (FOR A YEAR AND A HALF). PATIENT STATES THEY STILL HAVE PAIN; HOWEVER, THEY NO LONGER REQUIRE MEDICAL ATTENTION. THERE WAS NO REPORT OF DEVICE MALFUNCTION.

  Patient problems: Bone Fracture(s)

  MAUDE report 22798596 ↗
• MalfunctionAug 12, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN TO REPORT THE CONTROLLER,VEST 105,BT POWER CORD HAD COPPER WIRES EXPOSED. THIS OCCURRED AT HOME DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT. THE REPORTER DID NOT COMMUNICATE THIS EVENT TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22785151 ↗
• MalfunctionJul 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  BAXTER RECEIVED A REPORT STATING THAT VEST MODEL 105 POWER CORD HAD DAMAGE WITH EXPOSED COPPER WIRES. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470485 ↗
• MalfunctionJun 13, 2025Overheating of Device; Overheating of Device

  BAXTER RECEIVED A REPORT STATING THAT VEST 105 POWER CORD WAS VERY LOOSE AND MELTED ON THE END. THE BED WAS LOCATED AT THE ACCOUNT AND OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205143 ↗
• MalfunctionMay 28, 2025Sparking; Sparking

  BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN TO REPORT THE VEST MODEL 105 SERVICED IS SPARKING AND SMOKING. THE BED WAS LOCATED AT THE ACCOUNT.THIS OCCURRED AT HOME DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT. THE REPORTER DID NOT COMMUNICATE THIS EVENT TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096178 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT SUSTAINED A COMPRESSION FRACTION WHILE USING A VEST IN THE HOSPITAL. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR PNEUMONIA AND BRONCHIECTASIS POST BRONCHOSCOPY PROCEDURE. WHILE HOSPITALIZED THE PATIENT WAS BEING TREATED WITH THE HOSPITAL¿S DISPOSABLE VEST. ON AN UNKNOWN DATE THE PATIENT COMPLAINED OF ¿SEVERE BACK PAIN¿ AND UNDERWENT A COMPUTED TOMOGRAPHY SCAN (CT). THE CT SHOWED A COMPRESSION FRACTURE OF THE T6 VERTEBRA. THE PATIENT REPORTED THAT THE HEALTHCARE PROVIDER (HCP) COULD NOT TELL FOR CERTAIN IF THE USE OF THE DEVICE CAUSED THE INJURY BUT BASED ON THE LOCATION, THE HCP SUSPECTED THAT IT COULD HAVE CONTRIBUTED. PER THE PATIENT, THE HCP ALSO NOTED THAT THEIR COUGHING AND STEROID USE COULD ALSO HAVE CONTRIBUTED TO THE INJURY. IT WAS NOTED THAT THE PATIENT HAD TO WEAR A BACK BRACE TO RESTRICT THEIR MOVEMENT UNTIL THE FRACTURE EVENTUALLY HEALED WITHOUT FURTHER MEDICAL INTERVENTION. ADDITIONALLY, THERE WAS NO REPORT OF DEVICE MALFUNCTION. THE EXACT CAUSE IS UNKNOWN AT THIS TIME, BUT LIKELY MULTIFACTORIAL DUE TO THE PATIENT¿S MEDICAL HISTORY OF OSTEOPOROSIS AND COUGHING AND STEROID USAGE WHICH MAY HAVE BEEN CONTRIBUTING FACTORS. NO FURTHER INFORMATION

  Patient problems: Bone Fracture(s)

  MAUDE report 22078783 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT EXPERIENCED A MEDICAL CONDITION IN CONJUNCTION WITH A VEST SYSTEM. THE PATIENT EXPERIENCED REDNESS AND IRRITATION AROUND THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG/MICKEY) SITE. UPON FURTHER EXAMINATION, GRANULATION WAS OBSERVED AROUND THE MICKEY SITE. THE AREA WAS TREATED WITH ANTIBIOTIC CREAM, SILVER NITRATE TRIPLE ANTIBIOTIC OINTMENT, AND HYDROCORTISONE. THERE WAS NO REPORT OF DEVICE MALFUNCTION, AND THE DEVICE REMAINS WITH THE PATIENT FOR CONTINUED USE. AN IN-HOME PATIENT VISIT BY A RESPIRATORY CLINICIAN IS PLANNED TO REVIEW THERAPY, GARMENT FIT, AND FOAM CUSHIONING USE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Granuloma

  MAUDE report 22069708 ↗
• MalfunctionMay 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  BAXTER RECEIVED A REPORT STATING THAT VEST 105 POWER CORD WAS CUT IN HALF WITH EXPOSED COPPER WIRES. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962267 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE VEST APEX SYSTEM DID NOT PERFORM AS INTENDED. REPORTEDLY THE CAREGIVER NOTICED SINCE THE PATIENT BEGAN USING THE VEST DEVICE THE PATIENT DEVELOPED RECURRENT PNEUMONIA (PNA) INFECTIONS. IT USUALLY TAKES APPROXIMATELY TWO WEEKS TO DEVELOP PNA SYMPTOMS; HOWEVER, SINCE THE PATIENT STARTED ON VEST THERAPY THE ILLNESS DEVELOPED IN 36 HOURS. THE CAREGIVER STATED THAT THE DEVICE IS WORKING AS INTENDED; HOWEVER, ¿THEIR MUCUS CONSOLIDATED FASTER IN THE LUNGS AND CAUSED THE PATIENT TO GET SICKER FASTER TO A CRISIS POINT.¿ IT WAS NOTED THAT WHEN THE PATIENT WAS ADMITTED TO HOSPITAL ON THE DATE OF THE EVENT, ¿THEY NEEDED MORE SUPPORT THAN USUAL, REQUIRING HIGH FLOW OXYGEN.¿ ALSO NOTED, THE PATIENT STATED THAT THEY ALSO IMPROVED FASTER, AS IT USUALLY TAKES THEM ONE WEEK TO RECOVER, AND IN THIS CASE, IT TOOK THEM FIVE DAYS INSTEAD. THERE WAS NO REPORT OF DEVICE MALFUNCTION REPORTED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pneumonia

  MAUDE report 21931853 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A VEST SYSTEM CONTRIBUTED TO THE DISLODGEMENT OF A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WHEREIN THE PATIENT WAS HOSPITALIZED. THE PARENTAL CAREGIVER REPORTED THE PATIENT¿S PEG TUBE DISLODGED. IT WAS FURTHER REPORTED THAT THE PATIENT¿S HEALTHCARE PROVIDER IS UNSURE IF THE USE OF THE VEST SYSTEM CONTRIBUTED TO THE TUBE COMING OUT. THERE WAS NO REPORT OF DEVICE MALFUNCTION. THE PATIENT WAS HOSPITALIZED FOR THE PEG TUBE DISLODGEMENT AND ASPIRATION PNEUMONIA. AFTER SEVEN DAYS THE PATIENT WAS DISCHARGED. 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 21857494 ↗
• MalfunctionFeb 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN TO REPORT THE VEST, MODEL 105 BLE POWER CORD HAD COPPER WIRES EXPOSED. THIS OCCURRED AT HOME DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT. THE REPORTER DID NOT COMMUNICATE THIS EVENT TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21414743 ↗
• MalfunctionJan 16, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN TO REPORT THE VEST 105 POWER CORD HAD COPPER WIRES EXPOSED. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21173174 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A ROUTINE FOLLOW-UP CALL BY A BAXTER RESPIRATORY CLINICIAN WITH THE PATIENT, THE PATIENT REPORTED EXPERIENCING SHORTNESS OF BREATH THREE DAYS FOLLOWING INITIATION OF USE OF THE VEST DEVICE. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: Cardiac Arrest

  MAUDE report 20512932 ↗