35X-ST ProFlexx® 0015790Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00190790000585), received between Aug 7, 2017 and Nov 22, 2024 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (6 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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE END USER ADVISED THE STRETCHER WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT WHILE TRANSPORTING A PATIENT. IT WAS ALLEGED THE PATIENT WAS INJURED; HOWEVER, THERE HAVE BEEN NO ALLEGATIONS OF PRODUCT MALFUNCTION. NO ADDITIONAL DETAILS ON THE INCIDENT OR ALLEGED INJURY HAVE BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20759588 ↗
• MalfunctionNov 28, 2023Unintended Movement; Unintended Movement

  IT WAS ALLEGED WHILE UNLOADING A PATIENT FROM THE AMBULANCE, THE FOOT END MEDIC WAS UNAWARE THE STUDENT ASSISTANT RELEASED THE STRETCHER FROM THE SAFETY BAIL AND THE STRETCHER ROLLED OFF THE AMBULANCE DECK AND LOWERED TO THE GROUND. THERE WAS NO REPORT OF INJURY TO THE PATIENT OR THE MEDICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18222462 ↗
• InjurySep 28, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED WHILE UNLOADING A PATIENT FROM THE AMBULANCE THE "WHEEL TRAY" OF THE STRETCHER ALLEGEDLY DID NOT LOCK INTO POSITION AND THE STRETCHER LOWERED TO LOWEST POSITION. NO INJURY TO THE PATIENT WAS REPORTED BUT A MEDIC ALLEGED INJURY IN THE NATURE OF BACK PAIN AND SOUGHT MEDICAL EVALUATION. NO INFORMATION ON THE OUTCOME OF THE EVALUATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 17840036 ↗
• MalfunctionMay 11, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED WHILE UNLOADING A PATIENT FROM THE AMBULANCE, THE STRETCHER ALLEGEDLY DID NOT CATCH THE SAFETY HOOK AND THE STRETCHER TILTED TO THE SIDE. IT WAS ALLEGED THE PATIENT SUSTAINED INJURY DESCRIBED AS "RIGHT ELBOW PAIN/INJURY". MEDICAL INTERVENTION SOUGHT WAS AN XRAY. NO ADDITIONAL INFORMATION WAS PROVIDED ON THE ALLEGED INJURY OR THE OUTCOME OF THE MEDICAL INTERVENTION.

  Patient problems: Limb Pain

  MAUDE report 16911310 ↗
• InjuryOct 8, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED WHILE UNLOADING A PATIENT FROM THE AMBULANCE THE LATCH WAS PRESSED TOO EARLY BEFORE THE LEGS WERE DOWN CAUSING THE STRETCHER TO FALL WITH THE PATIENT. THE PATIENT REMAINED RESTRAINED TO THE STRETCHER, BUT ALLEGEDLY DID COMPLAIN OF RIGHT ELBOW PAIN AS A RESULT.

  Patient problems: Pain

  MAUDE report 9168165 ↗
• MalfunctionJun 21, 2019Unintended Movement; Material Twisted/Bent; Unintended Movement

  COMPLAINANT ALLEGES WHILE LOADING A PATIENT INTO THE AMBULANCE THE DROP FRAME ALLEGEDLY BENT WHEN THE FOOT END OF THE COT WAS LIFTED. THE OPERATORS THEN CHOSE TO HAVE THE PATIENT TRANSFERRED TO ANOTHER STRETCHER TO COMPLETE THE TRANSFER. NO INJURIES OR DELAY IN TREATMENT WERE REPORTED AS A RESULT OF THE INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8721964 ↗
• InjuryFeb 25, 2019Unintended Movement

  COMPLAINANT ALLEGES WHILE UNLOADING THE PATIENT FROM THE AMBULANCE, THE STRETCHER LEGS ALLEGEDLY DID NOT LOWER. THE STRETCHER THEN ROTATED TO THE RIGHT AND LANDED ON ITS SIDE. THE PATIENT REPORTED ALLEGED PAIN TO THE RIGHT FLANK.

  Patient problems: Pain

  MAUDE report 8366547 ↗
• MalfunctionOct 5, 2017Retraction Problem; Device Handling Problem; Device Handling Problem

  COMPLAINANT ALLEGED WHILE ATTEMPTING TO LOAD THE PATIENT, THE CREW WAS UNABLE TO RETRACT THE UNDERCARRIAGE. THE PATIENT WAS TRANSFERRED TO ANOTHER COT AND TRANSPORTED. NO INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6918321 ↗
• InjuryAug 7, 2017Detachment Of Device Component

  COMPLAINANT ALLEGES THAT WHILE LOADING A PATIENT INTO THE TRUCK, THE DISC/PUD AT THE HEADEND CAME OFF IN WHICH THE COT THEN LOWERED TO THE GROUND. PATIENT ALLEGES INJURY TO THE NECK, MEDIC ALLEGES INJURY TO THE BACK AND EMT ALLEGES INJURY TO THE HIP. NO FURTHER DETAILS IN REGARDS TO INJURIES SUSTAINED OR ADDITIONAL MEDICAL INTERVENTION HAVE BEEN PROVIDED.

  Patient problems: Injury

  MAUDE report 6772393 ↗