7mm extended length Endoscope C-VH-1111Recalls & reported problems
Maquet Cardiovascular LLC · 7mm extended length Endoscope · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Maquet 7mm endoscope has 200 adverse event reports, with no deaths and 2 injuries. Many reports describe poor or blurry images, along with breaks, cracks and loose parts, some noticed during cleaning or sterilizing. Reports dropped to 18 in the last 12 months from 31 in the 12 months before. There are no recalls that name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 205
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 205 adverse event reports that list this exact device (DI 00607567700802), received between Jul 15, 2020 and Sep 16, 2026 — classified as 2 injuries, 203 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (125 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.
Reports received per month
Most reported problems
Device problems
- Poor Quality Image125
- Break35
- Crack15
- Insufficient Device Problem Information13
- Detachment of Device or Device Component12
- Component Missing5
- Material Protrusion/Extrusion5
- Contamination /Decontamination Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions129
- Insufficient Information39
- No Patient Involvement27
- No Consequences Or Impact To Patient21
Recent adverse event reports
The 25 most recent of 205 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Moisture Damage
Patient problems: Insufficient Information
MAUDE report 50794922 ↗MalfunctionSep 16, 2026Break
The hospital reported that the the lens on the 7mm Extended Length Endoscope was broken. The issue involved a cracked lens, which was noticed by SPD prior to the device being sent to the OR. The issue occurred before the procedure. the patient was not in the OR.linked to (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50784978 ↗MalfunctionSep 15, 2026Break
The hospital reported that the the lens on the 7mm Extended Length Endoscope was broken. The issue involved a cracked lens, which was noticed by SPD prior to the device being sent to the OR. The issue occurred before the procedure. The patient was not in the OR.linked to (b)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774015 ↗MalfunctionSep 8, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50667091 ↗MalfunctionAug 11, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50207222 ↗MalfunctionAug 6, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50160090 ↗MalfunctionJul 30, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50082727 ↗MalfunctionMay 6, 2026Poor Quality Image
THE HOSPITAL REPORTED THAT THEY ARE HAVING A PROBLEM WITH A 7MM EXTENDED LENGTH ENDOSCOPE. THE SCOPE SHOWS A BLURRY PICTURE. THIS MALFUNCTION OCCURRED BEFORE PROCEDURE, NO PATIENT INVOLVEMENT. NO DELAY. NEW DEVICE WAS USED IN THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25095063 ↗MalfunctionApr 20, 2026Poor Quality Image
THE HOSPITAL REPORTED THAT 7MM EXTENDED LENGTH ENDOSCOPE WAS REPORTED AS HAVING A CLOUDY LENS AND BEING OLD. NO PATIENT HARM. THE ISSUE OCCURED IN STERILE PROCESS DEPARTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24925278 ↗MalfunctionApr 20, 2026Detachment of Device or Device Component
THE HOSPITAL REPORTED THAT THE BLACK EYE PIECE ON THE PROXIMAL END OF SCOPE OF THE 7MM EXTENDED LENGTH ENDOSCOPE IS LOOSE. THIS WAS NOTICED IN THE STERILE PROCESS DEPARTMENT WHEN CONNECTING TO THE NEW CAMARA. THIS INCIDENT DID NOT OCCUR DURING THE PROCEDURE. THERE WAS NO DELAY, AND NO PATIENT HARM AS THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24922818 ↗MalfunctionApr 16, 2026Poor Quality Image
MalfunctionApr 13, 2026Detachment of Device or Device Component
THE HOSPITAL REPORTED THAT 7 MM EXTENDED LENGTH ENDOSCOPE. O-RING INTO SCOPE DETACHED, A PHOTOGRAPH WAS PROVIDED. THE ISSUE WAS NOTICED BETWEEN THE WASHING PROCESS AND AUTOCLAVING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24854969 ↗MalfunctionFeb 25, 2026Poor Quality Image
THE HOSPITAL REPORTED BLURRY IMAGE OF THE 7MM EXTENDED LENGTH ENDOSCOPE. THE ISSUE OCCURRED BEFORE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. THERE WAS NO DELAY. THERE WAS NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24440304 ↗MalfunctionJan 29, 2026Poor Quality Image
THE HOSPITAL REPORTED THAT THE SCOPE WAS BLURRY. THE ISSUE HAPPENED AT THE START OF THE CASE (CABG). THE HARVESTING TOOL WAS ADVANCED UNDER ENDOSCOPIC VISUALIZATION DURING INTIAL INSERTION. NO DELAY OCCURED. A REPLACEMENT SCOPE WAS REQUESTED AND THE CASE WAS COMPLETED. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24207985 ↗MalfunctionDec 23, 2025Crack; Poor Quality Image; Crack; Poor Quality Image
THE HOSPITAL REPORTED THAT DURING VEIN HARVESTING PROCEDURE SOME ENDOSCOPES WERE NOT CENTERING PROPERLY ON THE MONITOR AND INTERMITTENTLY LOST LIGHT AND CAMERA VISUALIZATION. CUSTOMER REPORTS THAT SOME UNITS WERE ALSO FOUND TO HAVE CRACKS IN THE BLACK EYE PIECE.
Patient problems: Insufficient Information
MAUDE report 23875693 ↗MalfunctionDec 23, 2025Crack; Poor Quality Image; Crack; Poor Quality Image
THE HOSPITAL REPORTED THAT DURING VEIN HARVESTING PROCEDURE SOME ENDOSCOPES WERE NOT CENTERING PROPERLY ON THE MONITOR AND INTERMITTENTLY LOST LIGHT AND CAMERA VISUALIZATION. CUSTOMER REPORTS THAT SOME UNITS WERE ALSO FOUND TO HAVE CRACKS IN THE BLACK EYE PIECE.
Patient problems: Insufficient Information
MAUDE report 23875690 ↗MalfunctionDec 23, 2025Crack; Poor Quality Image; Crack; Poor Quality Image
MalfunctionDec 22, 2025Crack; Poor Quality Image; Crack; Poor Quality Image
THE HOSPITAL REPORTED THAT DURING VEIN HARVESTING PROCEDURE SOME ENDOSCOPES WERE NOT CENTERING PROPERLY ON THE MONITOR AND INTERMITTENTLY LOST LIGHT AND CAMERA VISUALIZATION. CUSTOMER REPORTS THAT SOME UNITS WERE ALSO FOUND TO HAVE CRACKS IN THE BLACK EYE PIECE.
Patient problems: Insufficient Information
MAUDE report 23874115 ↗MalfunctionDec 8, 2025Poor Quality Image; Poor Quality Image
THE HOSPITAL REPORTED THAT THERE IS A BLACK LINE THROUGH CENTER OF VISUAL FIELD OF 7MM EXTENDED LENGTH ENDOSCOPE.
Patient problems: Insufficient Information
MAUDE report 23741174 ↗MalfunctionNov 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
MalfunctionNov 19, 2025Poor Quality Image; Poor Quality Image
THE HOSPITAL REPORTED THAT THEIR VH-1111 'GOES BLACK,' THE IMAGE BLACKS OUT. THE PROBLEM WAS FOUND DURING STERILE PREP, NO PATIENT EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23592693 ↗MalfunctionNov 17, 2025Poor Quality Image; Poor Quality Image
THE HOSPITAL REPORTED THAT 7MM EXTENDED LENGTH ENDOSCOPE IMAGE WAS EXTREMELY CLOUDY. THE CALLER DID NOT KNOW WHEN OR HOW THE PROBLEM WAS DISCOVERED AND DID NOT HAVE PATIENT EFFECT INFORMATION.
Patient problems: Insufficient Information
MAUDE report 23577741 ↗MalfunctionNov 11, 2025Poor Quality Image; Poor Quality Image
MalfunctionOct 29, 2025Poor Quality Image; Poor Quality Image
MalfunctionSep 9, 2025Poor Quality Image; Poor Quality Image
THE HOSPITAL REPORTED THAT AFTER THE CASE, THE 7MM EXTENDED LENGTH ENDOSCOPE WAS SENT TO THEIR CLINICAL ENGINEERING DEPARTMENT WITH COMPLAINTS OF THE SCOPE BEING "VERY BLURRY". THE ENDOSCOPE WAS ASSESSED BY CLINICAL ENGINEERING AND VERY LIMITED FOGGY SPOTS WERE FOUND THAT COULD BE CAUSING THE END USERS TO HAVE TROUBLE USING THE SCOPE. THE TIP ENDOSCOPE WAS CLEANED BUT WITH NO SUCCESS. NO INJURIES OCCURRED DUE TO THIS DEFECT AND THERE WERE NO SURGICAL DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23003435 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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