CytoMax II G22674Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002226746), received between Apr 10, 2017 and Dec 22, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY [ERCP], THE PHYSICIAN USED A COOK CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH. IT WAS REPORTED [THAT] DURING SAMPLE COLLECTION, 1.5 CM OF THE TIP OF THE [DEVICE] DETACHED FROM THE BRUSH AND REMAINED INSIDE THE PATIENT'S BILE DUCT. A SECTION OF THE DEVICE WAS TEMPORARILY LEFT INSIDE THE PATIENT¿S BODY. THE TIP WAS FOUND AND REMOVED FROM THE PATIENT IN A SEPARATE PROCEDURE ON (B)(6) 2025. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY FURTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23872401 ↗
• InjuryDec 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY [ERCP], THE PHYSICIAN USED A COOK CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH. IT WAS REPORTED [THAT] THE DOCTOR USED BRUSH TO COLLECT CELLS FROM THE HEPATIC DUCT ON (B)(6) 2024. THE PROCEDURE WAS FINISHED AND PATIENT WENT THROUGH CT SCAN AFTERWARDS [ON (B)(6) 2025]. FROM THE CT SCAN REPORT, DOCTOR FOUND OUT THERE MIGHT BE SOME FOREIGN BODY INSIDE PATIENT AND HENCE THEY DID ANOTHER CHECK UP AND FOUND A BROKEN FILIFORM TIP INSIDE PATIENT'S DUCT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE TIP WAS FOUND AND RETRIEVED IN RECENT CHECK UP ON (B)(6) 2025. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23789560 ↗
• MalfunctionJul 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH. THE USER OPENED THE PACKAGE AND ADVANCED THE DEVICE INTO THE ENDOSCOPE. [THE USER] FOUND THAT THERE WAS NO BRUSH ON THE DEVICE, ONLY THE SHEATH OF THE CATHETER. ADDITIONAL INFORMATION WAS RECEIVED ON 09-JUL-2019: ONLY THE CLEAR OUTER PLASTIC SHEATH WAS WITH THE DEVICE AND THE INNER WIRE WITH THE BRUSH WAS NOT WITH THE DEVICE. ADDITIONAL INFORMATION WAS RECEIVED ON 11-JUL-2019: THE DEVICE WAS NOT CHECKED PRIOR TO INSERTION TO THE ENDOSCOPE. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. THE LOCATION OF THE MISSING PORTION OF THE DEVICE IS UNKNOWN. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8804305 ↗
• MalfunctionApr 10, 2017Break; Break

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH. THE NURSE TRIED TO HANDLE [ADVANCE] THE SHEATH BACK AND FORTH, BUT FOUND THAT THE BRUSH WAS DISCONNECTED FROM THE SHEATH. ANOTHER OF THE SAME DEVICE WAS USED WITHOUT A PROBLEM. THE CYTOLOGY PROCEDURE WAS COMPLETED SUCCESSFULLY. A PHOTO WAS RECEIVED OF THE DEVICE. THE CYTOLOGY BRUSH HAS BROKEN AND DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6477177 ↗