ManoScan 1286Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04260167482484), received between Apr 16, 2019 and Dec 2, 2025 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Difficult to Insert; Difficult to Remove; Material Deformation; Difficult to Insert; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT THE CATHETER HAD A DISLODGED SILICONE PIECE AND HAD DIFFICULTY INSERTING AND REMOVING IT. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692639 ↗
• MalfunctionAug 27, 2024Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THERE WAS AN ISSUE REMOVING THE CATHETER AS THE DISTAL PART WAS A BIT DESTROYED. THERE WAS NO PROBLEM REMOVING IT FROM THE PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20081271 ↗
• InjuryMay 22, 2024Difficult to Remove; Insufficient Device Problem Information; Difficult to Remove; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE CATHETER STUCK IN PATIENT, COULD NOT BE REMOVED BY PHYSICIAN WHO MADE THE PROCEDURE AND ENT DEPARTMENT FINALLY REMOVED THE CATHETER USING A DEVICE. IT HAD A LITTLE RUPTURE IN WHITE ISOLATION RIGHT AFTER THE SENSOR PART. LITTLE BLEEDING APPEARED ON THE PATIENT. THERE WAS A KIND OF TEAR/ LACERATION ON THE MUCOSA, PROBABLY FROM THE CUT IN THE CATHETER ISOLATION THAT GOT CAUGHT ON THE MUCOSA.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 19371097 ↗
• MalfunctionDec 19, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE CATHETER CANNOT BE PULLED OUT AND FELT SIGNIFICANT RESISTANCE AT THE BACK OF THE NOSE AND JOINT OF THE CATHETER. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18359395 ↗
• MalfunctionDec 6, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE CATHETER CANNOT BE PULLED OUT AFTER THE PROCEDURE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18279870 ↗
• MalfunctionOct 4, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE CATHETER WAS UNABLE TO REMOVE AND STUCK IN THE PATIENT'S NOSE. IT WAS DESCRIBED AS "STUCK AT THE JUNCTION WHERE THE SENSORS MEET THE WHITE TUBE ON THE PROBE (APPROX 37.5 ), THE CATHETER WAS CUT WITH A PAIR OF SCISSORS AND PULLED OUT VIA PATIENT MOUTH. AFTER RINGING THE PATIENT TWO DAYS LATER, PATIENT REPORTED A SORE NOSE, SOME BLEEDING AND UNABLE TO BREATHE THROUGH THIS NOSTRIL.

  Patient problems: Dyspnea; Obstruction/Occlusion; Pain

  MAUDE report 17866226 ↗
• MalfunctionOct 3, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE CATHETER WAS STUCK IN PATIENT NOSE WHILE EXTUBATING. THE PROBE WAS CUT AND PULLED OUT THROUGH THE MOUTH. THE PATIENT WAS A LITTLE SHAKEN UP, WITH A SORE NOSE, BUT ULTIMATELY FINE. AFTER RINGING THE PATIENT TWO DAYS LATER, PATIENT REPORTED A SORE NOSE, SOME BLEEDING, AND UNABLE TO BREATHE THROUGH A NOSTRIL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 17865220 ↗
• InjuryAug 31, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE CATHETER WAS INSERTED VIA NOSTRIL WITHOUT ANY RESISTANCE TO 52 CM. THE PROCEDURE WENT WELL WITH ROUTINE WATER SWALLOW WITHOUT ANY COMPLICATIONS. WHEN THE CATHETER WAS PULLED OUT, IT GOT STUCK AT 46CM AND WOULD NOT RETRIEVE FURTHER. AT 46CM MARK, A SMALL TEAR ON THE PLASTIC SHEATH WAS VISIBLE. TO INVESTIGATE FURTHER THE PATIENT WAS SWIFTLY MOVED TO THE ENDOSCOPY ROOM AND ANESTHETIZED UNDER THE ANESTHETIC WITH AN ENDOTRACHEAL TUBE INSERTED. THE ENDOSCOPE WENT INTO THE ESOPHAGUS AND THE TIP OF THE MANOMETRY CATHETER WAS SITTING ABOVE THE CARDIO ESOPHAGEAL JUNCTION AS EXPECTED. NO MECHANICAL OBSTRUCTION WAS SEEN IN THE ENTIRE ESOPHAGUS OR IN THE OROPHARYNX. THE WHITE PART OF THE CATHETER WAS NOT VISUALIZED, AND THE "OBSTRUCTION" WAS FELT TO BE IN THE NASAL PASSAGE. THE NASAL PASSAGE WAS EXAMINED USING A FLEXIBLE NASAL ENDOSCOPY. THE PATIENT HAS A DEVIATED SEPTUM TO THE RIGHT NOSTRIL AND ENLARGED TURBINATE. THE TORN PLASTIC SHEATH WAS FELT TO BE CAUGHT IN THE NARROW PASSAGE PREVENTING THE CATHETER FROM BEING REMOVED. THE PHYSICIAN GRADUALLY MANEUVERED THE CATHETER UNDER VISUALIZATION AND MANAGED TO RETRIEVE IT WITH THE SHEATH INTACT. NO FORCEPS WERE REQUIR

  Patient problems: Sore Throat

  MAUDE report 17667489 ↗
• MalfunctionAug 4, 2022Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE CATHETER HAD TO BE CUT TO BE REMOVED FROM PATIENT. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 15169874 ↗
• InjurySep 25, 2019Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, AT THE END OF THE STUDY, IT WAS DIFFICULT TO EXTUBATE THE PATIENT. THE PROBE GOT STUCK AND THE PATIENT WAS THEN SENT TO THE EMERGENCY ROOM WHERE A CHEST AND HEAD X-RAY WAS TAKEN WHICH SHOWED NORMAL, VALIUM WAS GIVEN, AND THE PROBE WAS REMOVED. DURING THE RECOVERY PERIOD, THE PATIENT EXPERIENCED INCREASED, UNSTOPPABLE NASAL BLEEDING, AND HAD TO RETURN TO THE EMERGENCY ROOM FOR NASAL PACKING AND AN OVERNIGHT STAY FOR OBSERVATION. THERE WAS A TEAR IN THE OUTER COVERING OF THE PROBE RELATED TO THE REMOVAL AND NOT TO THE INSERTION OR PERFORMANCE DURING THE PROCEDURE.

  Patient problems: Blood Loss; Radiation Exposure, Unintended

  MAUDE report 9115414 ↗
• MalfunctionApr 16, 2019Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  ACCORDING TO THE REPORTER, THE CATHETER'S TPE HAD A HOLE NEAR THE METAL RING AT THE MARKER 47-48, BUT IT WORKED CORRECTLY DURING A PREVIOUS PROCEDURE. THE PROBE GOT STUCK IN THE PATIENT DUE TO A RAISED EDGE WHERE THE SENSORS JOIN WITH THE REST OF THE PROBE. THE CATHETER WAS REMOVED WITHOUT ANY INTERVENTION REQUIRED. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8519401 ↗