Cook G22181Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002221819), received between Feb 23, 2018 and Jun 27, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2025Break; Dent in Material; Break; Dent in Material

  DESCRIPTION OF EVENT: AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN UNSPECIFIED PROCEDURE IN WHICH THE COLON COMPRESSION SET, G22181, WAS USED. WHEN THE TUBE WAS PLACED, STAFF TRIED TO TAKE OUT INNER TUBE (BLACK TUBE PLUS WIRE) IT KINKED ON THE INSIDE AND BROKE INTO TWO PIECES. THE PROCEDURE WAS COMPLETED USING A DIFFERENT SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344441 ↗
• InjuryFeb 27, 2024Off-Label Use; Off-Label Use

  COMPLETE REPORT BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON THE 17TH MAY 24.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18789080 ↗
• MalfunctionOct 4, 2023Difficult to Remove; Difficult to Remove

  COMPLAINT FORM COMPLETED. LBE01 (18 SEPTEMBER 2023). HAD DIFFICULTY WHEN TRYING TO SEPARATE THE GREY INNER TUBE FROM THE OUTER WHITE CASING EVEN AFTER FLUSHING AND FOLLOWING THE IFU. ENDED UP USING A NEW COLON DECOMPRESSION KIT. THE NEXT DAY IT APPEARED TO SEPARATE EASILY. ON FRIDAY NIGHT, (B)(6) 2023, CUSTOMER HAD DIFFICULTY WHEN TRYING TO SEPARATE THE GREY INNER TUBE FROM THE OUTER WHITE CASING. THEY ENDED UP USING A NEW SET. THE NEXT DAY, IT APPEARED TO SEPARATE EASILY.

  Patient problems: Insufficient Information

  MAUDE report 17868695 ↗
• MalfunctionNov 10, 2022Material Fragmentation; Off-Label Use; Material Fragmentation; Off-Label Use

  THIS FOLLOW UP CANCELLATION REPORT IS BEING SUBMITTED AS THE DEVICE USED IN THE PROCEDURE WAS CONFIRMED TO BE NOT USED AS OFF-LABEL ON 10-NOV-2022. "USAGE OF CDSG FOR FLEXIBLE SIGMOIDOSCOPY IS NOT OFF-LABEL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15769822 ↗
• MalfunctionMar 29, 2022Break; Break

  REPORTED BY THE DM ON BEHALF OF THE CUSTOMER'S EMAIL - UPON REMOVAL OF WIRE AT THE INNER CANNULA THE INNER CANNULA BROKE. ALL PRODUCT WAS REMOVED FROM THE PATIENT NO INJURY. PRODUCT WAS DISCARDED DUE TO SOILED CONDITION. THE FOLLOWING HAS BEEN REQUESTED- (B)(4). 02MAR2022. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? IF YES, PLEASE DESCRIBE. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE THIS OCCURRENCE? THE FOLLOWING HAS BEEN REQUESTED- (B)(4) 02MAR2022 WAS THE DEVICE FLUSHED BEFORE USE? N/A, YES, NO 1.1.2 WHAT WAS FLUSHED THROUGH THE DEVICE (WATER, SALINE, ETC.)? N/A, WATER, SALINE, OTHER IF OTHER PLEASE SPECIFY. 1.1.3 WAS LUBRICATION APPLIED TO THE DECOMPRESSION TUBE? N/A YES, NO. 1.1.4

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13937514 ↗
• MalfunctionMar 9, 2022Break; Break

  COLON DECOMPRESSION TUBE WAS PLACED IN COLON. UPON TRYING TO WITHDRAWAL INNER GUIDING CATHETER FROM OUTER DRAINAGE TUBE, RESISTANCE WAS FELT AND THE INNER GUIDING CATHETER BROKE IN TWO PIECES. ONE PIECE OF BROKEN INNER GUIDING CATHETER CAME OUT OF THE OUTER DRAINAGE TUBE, WHILE THE OTHER PIECE WAS STUCK INSIDE THE DISTAL END OF THE OUTER DRAINAGE TUBE. COLON DECOMPRESSION TUBE, WITH BROKEN PIECE OF INNER GUIDING CATHETER, WAS THEN REMOVED FROM PATIENT. TO FINISH THE PROCEDURE, A NEW DEVICE OF THE SAME TYPE WAS PLACED AND NO OTHER ISSUES WERE ENCOUNTERED. I RECOMMENDED CUSTOMER DISASSEMBLE COLON DECOMPRESSION SET AND FLUSH AND LIBERALLY LUBRICATE EACH PIECE AND THEN REASSEMBLE BEFORE PLACEMENT. I ALSO RECOMMENDED USING A SHAKING MOTION WHEN WITHDRAWING INNER GUIDING CATHETER. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. IF YES, PLEASE DESCRIBE. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? NO. IF YES, PLEASE DESCRIBE. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. IF YES, PLEASE DESCRIBE. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. IF YES,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13706025 ↗
• MalfunctionFeb 15, 2022Break; Break

  THE INNER CATHETER GOT STUCK AND SNAPPED WHEN TAKEN OUT. THE BROKEN PART WAS THEN FINALLY PULLED OUT. NO PATIENT INJURY. PRODUCT AND PACKAGE DISPOSED OF. "AS PER CC FORM": THE INNER CATHETER GOT STUCK AND SNAPPED WHEN TAKEN OUT. THE BROKEN PART WAS THEN FINALLY PULLED OUT. NO PATIENT INJURY. PRODUCT AND PACKAGE DISPOSED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13534106 ↗
• MalfunctionJan 25, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  "THE GUIDE WIRE BROKE UPON REMOVAL OF THE GUIDE WIRE FROM THE DEVICE. ADDITIONAL INFORMATION: THEY DID NOT LUBRICATE THE INNER OR OUTER CATHETERS PER THE IFU, NOR DID THEY FLUSH THE GUIDE WIRE PORT AS STATED IN THE IFU. IN FACT, THE NURSE CALLED THE ON-CALL NUMBER TO ASK WHAT SHOULD BE ATTACHED TO THE EXTERNAL END OF THE TUBE TO COLLECT WASTE. UPON FURTHER DISCUSSION, THEY DID NOT EVEN REMOVE THE INNER GUIDING CATHETER NOR DO THE PROCEDURE UNDER FLUOROSCOPY." I ASKED IF ANY PART OF THE WIRE REMAINED IN THE PATIENT, IN WHICH, (B)(6) WASN¿T SURE. SHE THOUGHT THEY GOT IT ALL BUT COULDN¿T CONFIRM. BEFORE GETTING OFF THIS INITIAL CALL, SHE WAS GOING TO ASK THE DOCTOR TO ORDER AN X-RAY TO CONFIRM, IN WHICH, THE PHYSICIAN THAT PLACED THE TUBE DENIED TO DO (ON A SECOND, FOLLOW-UP PHONE CALL)- THIS IS ACCORDING TO (B)(6). ADDITIONALLY, I ASKED HOW THEY WERE GOING TO REMOVE THE INNER TUBE BECAUSE WITHOUT IT REMOVED, THE COLON DECOMPRESSION TUBE CANNOT DO IT¿S JOB. ON THE SECOND CALL, SHE ALSO INFORMED ME THE DOCTOR DENIED TO RETURN TO REMOVE THE INNER CATHETER, TELLING THE NURSE TO DO SO. THE NURSE ASKED IF IT WAS IN HER SCOPE OF PRACTICE IN WHICH I TOLD HER ¿I¿M NEITHER A NURSE OR PHYSICIAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13342714 ↗
• InjuryFeb 23, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING PULLOUT, THERE IS SHEANING OF INNERLINE.

  Patient problems: No Code Available

  MAUDE report 7291634 ↗