ManoScanRecalls & reported problems across all models
Given Imaging, Inc. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 115
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls
- 0
We found 8 models of ManoScan by Given Imaging, Inc. in the FDA's device registry (GUDID). Together they are named in 115 adverse event reports in the FDA's MAUDE database, received between May 9, 2018 and Sep 18, 2026 — classified as 38 injuries, 77 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (100 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ManoScan problems
Device problems
- Difficult to Remove100
- Material Integrity Problem18
- Material Deformation13
- Insufficient Device Problem Information11
- Adverse Event Without Identified Device or Use Problem5
- Poor Quality Image4
- Break2
- Difficult to Insert2
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- Hemorrhage/Blood Loss/Bleeding15
- No Consequences Or Impact To Patient9
- Pain9
- Foreign Body In Patient8
- Airway Obstruction7
- Blood Loss7
- Unspecified Tissue Injury6
ManoScan models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ManoScan 3890SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)90 reports
- ManoScan 1286SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)11 reports
- ManoScan RFG-3890SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)8 reports
- ManoScan 3885SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)2 reports
- ManoScan 2192SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)1 report
- ManoScan RFG-1286SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)1 report
- ManoScan MSS-4581-3DSYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)1 report
- ManoScan MSS-3598SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)1 report
Recent ManoScan adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Difficult to Insert; Difficult to Remove; Loss of Data
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829201 ↗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 ↗InjuryJun 20, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE IMPEDANCE CATHETER GOT STUCK IN A PATIENT¿S NARES. IT WAS INSERTED EASILY AND THE TEST COMPLETED, BUT UPON REMOVAL IT ONLY CAME OUT TO THE 41CM MARK (ABOUT 10 CM). IT COULD NOT BE REMOVED BY EITHER THE NURSES OR DOCTOR WITH THE PATIENT AWAKE AS SIGNIFICANT NASAL PAIN AND EMOTIONAL DISTRESS EXPERIENCED. PATIENT WAS THUS SEDATED IN THE ENDOSCOPY SUITE AND A GASTROSCOPY WAS DONE TO ENSURE THE CATHETER WAS NOT ¿STUCK¿ IN THE ESOPHAGUS OR STOMACH. EVERYTHING LOOKED NORMAL BELOW THE UPPER ESOPHAGEAL SPHINCTER, SO THE ISSUE OF RESISTANCE WAS IN THE PATIENT'S NASAL CAVITY. AFTER SEVERAL ATTEMPTS THE PHYSICIAN WAS ABLE TO REMOVE IT AND THE PATIENT WAS RECOVERED FROM SEDATION.
Patient problems: Distress; Pain
MAUDE report 22297286 ↗MalfunctionJun 18, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE PROBE BECAME STUCK IN THE PATIENT'S NASAL PASSAGE UPON REMOVAL. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22283316 ↗MalfunctionMar 4, 2025Difficult to Remove; Insufficient Device Problem Information; Difficult to Remove; Insufficient Device Problem Information
IT WAS REPORTED THAT THE CATHETER WHITE PLASTIC HAS DISLODGED AND, ALTHOUGH IT CALIBRATES AND WORKS CORRECTLY, WHEN THE CATHETER WAS REMOVED FROM THE PATIENT¿S NOSE, IT BECOMES STUCK. THE CATHETER WAS REMOVED CAREFULLY. THERE WAS NO ANY ADDITIONAL DEVICE NEEDED TO REMOVE THE CATHETER FROM THE PATIENT. THERE WAS NO PATIENT OR USER HARM. .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21516318 ↗MalfunctionJan 24, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT A CATHETER BECAME STUCK IN THE PATIENT'S NARES DURING ITS REMOVAL. THERE WAS NO PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21228819 ↗InjuryOct 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ESOPHAGOGASTRODUODENOSCOPY ASSIST. IT WAS CONFIRMED TO BE IN THE STOMACH. WHILE THE PATIENT WAS IN THE RECOVERY WAITING ROOM, THE "VOMITING" STARTED. IT WAS OBSERVED THAT THE CATHETER COILED UP IN THE BACK OF THE PATIENT¿S THROAT, FURTHER STIMULATING THE GAG REFLEX. THERE WAS NO DIFFICULTY PULLING THE CATHETER FROM THE PATIENT. NO RESISTANCE FELT. THE PATIENT WAS FINE, AND THE VOMITING STOPPED AFTER THE CATHETER WAS REMOVED. NO OTHER DEVICES WERE USED TO REMOVE THE CATHETER. IT WAS PULLED OUT IN THE MANNER OF REMOVING AN NG TUBE. AN X-RAY WAS ORDERED TO CONFIRM THAT THERE WAS NO INJURY.
Patient problems: Vomiting
MAUDE report 20510247 ↗InjurySep 25, 2024Difficult to Remove; Insufficient Device Problem Information; Difficult to Remove; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, THE CATHETER GOT STUCK IN PATIENT'S NOSE. ENT (EAR, NOSE, THROAT) TEAM TOOK ONE OF ENT (EAR, NOSE, THROAT) SCOPES AND CUT THE DEVICE TO GET IT OUT OF PATIENT'S NOSE. FORCEPS WAS ALSO USED TO REMOVE THE CATHETER FROM THE PATIENT. THE CATHETER WAS DAMAGED.
Patient problems: Airway Obstruction
MAUDE report 20305248 ↗InjurySep 24, 2024Difficult to Remove; Difficult to Remove
ACCORDING TO THE REPORTER, THE CATHETER GOT STUCK IN A PATIENT'S NOSE AND HAD TO BE REMOVED. THE CATHETER WAS CUT, PUSHED THROUGH THE PATIENT'S NOSE AND PULLED OUT OF MOUTH WITH FORCEPS. THE EAR, NOSE AND THROAT SPECIALIST TOOK A SCOPE TO LOOK IN PATIENT'S NOSE PRIOR TO PULLING DEVICE OUT AND AFTER REMOVAL. THE CATHETER WAS DAMAGED.
Patient problems: Airway Obstruction
MAUDE report 20294610 ↗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 ↗MalfunctionJul 22, 2024Poor Quality Image; Difficult to Remove; Poor Quality Image; Difficult to Remove
ACCORDING TO THE REPORTER, THE CATHETER HAD GREY LINES ON STUDY. IT WAS STUCK ON PATIENT WHEN BEING REMOVED. PATIENT TURNED PROBE AND IT CAME OUT. PATIENT HAD A BLOODY NOSE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 19792778 ↗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 ↗MalfunctionMay 15, 2024Poor Quality Image; Difficult to Remove; Material Deformation; Poor Quality Image; Difficult to Remove; Material Deformation
ACCORDING TO THE REPORTER, THE CATHETER WAS DAMAGED DURING A DIFFICULT EXTUBATION. WHEN CALIBRATION WAS ATTEMPTED, IT SHOWED MULTIPLE PRESSURE BANDS. THE TPE SENSORS ALSO FELT TO BE STICKING OUT FURTHER THAN THE OTHER CATHETER. THERE WAS NO PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19325619 ↗MalfunctionApr 16, 2024Difficult to Remove; Insufficient Device Problem Information; Difficult to Remove; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, THE CATHETER WAS DAMAGED. THE INNER WHITE LINING IS DEGRADED <(>&<)> STRUCTURE IS COMPROMISED. A PROBLEM WAS ENCOUNTERED AT THE END OF THE STUDY AT NASAL CANAL, THE CATHETER WAS DIFFICULT TO EXTUBATE, IT WAS STUCK. THERE WAS NO MEDICAL INTERVENTION PERFORMED TO REMOVE THE CATHETER. THERE WAS NO PATIENT AND USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19116484 ↗MalfunctionMar 29, 2024Difficult to Remove; Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information; Difficult to Remove; Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, THE CATHETER WAS DIFFICULT TO INTUBATE AND EXTUBATE AS THE SENSORS APPEARED TO BE MISALIGNED, THIS WAS THE FIRST USE OF THE CATHETER. THERE WAS NO PATIENT AND USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19003750 ↗
Other Given Imaging, Inc. products
All Given Imaging, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page