Cook G09766Recalls & reported problems
Cook Incorporated · Multipurpose Drainage Catheter Ultrathane · Class U · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Cook G09766 Ultrathane drainage catheter is placed through the skin into the kidney to drain urine. The 26 reports mostly describe problems during placement — the stiffening cannula being hard to remove, a suture or the stiffener breaking into pieces inside the catheter, and instances of the device arriving contaminated. There were 4 injuries, no deaths, and no reports in the last 12 months. No recalls 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
- 26
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00827002097667), received between Aug 17, 2016 and Jul 22, 2025 — classified as 4 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (16 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove16
- Material Separation5
- Difficult to Advance3
- Break2
- Device Contaminated During Manufacture or Shipping2
- Detachment of Device or Device Component1
- Difficult to Insert1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Known Impact Or Consequence To Patient8
- Insufficient Information4
- No Code Available2
- No Consequences Or Impact To Patient2
- Discomfort1
- No Patient Involvement1
- Pain1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22566157 ↗MalfunctionJul 5, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE STIFFENING CANNULA WAS UNABLE TO BE REMOVED FROM AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER DURING A PLACEMENT PROCEDURE VIA A STOMA INTO THE KIDNEY. THE PROCEDURE WAS COMPLETED USING A COMPETITOR'S DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19681193 ↗InjuryDec 13, 2023Break; Break
IT WAS REPORTED THAT THE SUTURE OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER BROKE. THE DEVICE WAS REQUIRED FOR A NEPHROSTOMY. DURING ADVANCEMENT OF THE CATHETER OVER THE WIRE GUIDE, THE SUTURE BROKE. AN ADDITIONAL CATHETER WAS OBTAINED AND WAS PLACED IN THE PATIENT. THE SUTURE WAS "GENTLY" PULLED TO FORM THE PIGTAIL, AND THE SUTURE BROKE. THE PHYSICIAN ELECTED TO KEEP THE CATHETER IN PLACE WITHOUT THE SUTURE FOR SECUREMENT. IT WAS REPORTED THAT THE PATIENT WILL REQUIRE AN ADDITIONAL PROCEDURE TO REPLACE THE CATHETER. IT WAS NOTED THAT THE SUTURE STRING WAS CLEAR AND DIFFICULT TO SEE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. THIS REPORT CAPTURES THE SECOND CATHETER WITH BROKEN SUTURE THAT REQUIRES AN ADDITIONAL PROCEDURE FOR REPLACEMENT.
Patient problems: Insufficient Information
MAUDE report 18318028 ↗MalfunctionOct 9, 2023Difficult to Remove; Difficult to Remove
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17901350 ↗MalfunctionJul 11, 2023Difficult to Remove; Difficult to Remove
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17302063 ↗MalfunctionJun 28, 2023Material Separation; Material Separation
PER ADDITIONAL INFORMATION PROVIDED ON 25JUL2023, THE PATIENT HAD AN ILEAL CONDUIT BILATERAL PERCUTANEOUS NEPHROSTOMY EXCHANGE PROCEDURE WHICH REQUIRED LONGER FLUORO TIME AND LAYING ON THE TABLE. THE BLUE FLEXIBLE STIFFENER BROKE APART INTO TWO PIECES. THE FRAGMENT WAS STUCK INSIDE OF THE CATHETER BUT WAS REMOVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17218501 ↗MalfunctionJun 28, 2023Difficult to Remove; Stretched; Difficult to Remove; Stretched
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17218210 ↗InjuryApr 28, 2023Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Discomfort; Pain
MAUDE report 16832359 ↗MalfunctionApr 17, 2023Difficult to Remove; Difficult to Remove
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16754437 ↗MalfunctionApr 17, 2023Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE FLEXIBLE STIFFENERS WERE DIFFICULT TO REMOVE FROM TWO ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETERS DURING A BILATERAL RETROGRADE NEPHROSTOMY DRAINAGE CATHETER EXCHANGE PROCEDURE FOR A FEMALE PATIENT. THE EXISTENT 10 FR 45 CM CATHETERS WERE EXCHANGED OVER 0.35 STIFF GUIDEWIRES WITH NEW SAME CATHETERS WITHOUT ISSUE. BUT, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE FLEXIBLE STIFFENING CANNULAS FROM THE CATHETERS, THEY WOULD NOT WITHDRAW. THE CATHETER MATERIAL COULD BE SEEN STRETCHING. THE PHYSICIAN REMOVED THE CATHETERS AND STIFFENERS TOGETHER AND WAS ABLE TO SEPARATE THEM ON THE BACK TABLE BUT WITH MUCH DIFFICULTY. HE THEN REPLACED THE CATHETERS OVER THE SAME GUIDEWIRES INTO PATIENT BUT WITHOUT THE INNER STIFFENERS. NO ADDITIONAL PROCEDURES WERE PERFORMED. AS REPORTED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS BECAUSE OF THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16754254 ↗MalfunctionMar 28, 2023Difficult to Remove; Difficult to Remove
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16631800 ↗MalfunctionMar 14, 2023Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE STIFFENER OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS DIFFICULT TO REMOVE DURING AN UNSPECIFIED PROCEDURE ON AN UNKNOWN PATIENT. THE PHYSICIAN HAD TO CUT THE STIFFENER IN ORDER TO REMOVE IT FROM THE CATHETER. IT WAS CONFIRMED THAT THE DEVICE WAS SUCCESSFULLY PLACED AND DRAINING AS EXPECTED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND DEVICE RETURN HAVE BEEN REQUESTED BUT ARE CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16539720 ↗MalfunctionApr 26, 2022Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE FLEXIBLE STIFFENER OF TWO ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETERS WERE DIFFICULT TO REMOVE DURING A URETEROSTOMY TUBE EXCHANGE PROCEDURE ON AN UNKNOWN PATIENT. ACCORDING TO STANDARD PRACTICE, THE CATHETER WAS BEING EXCHANGED AFTER TWO MONTHS OF USE. THE WIRE GUIDE WAS ADVANCED IN ORDER TO REMOVE THE EXISTING CATHETER FROM THE PATIENT. A NEW CATHETER WAS THEN ADVANCED OVER THE WIRE AND PLACED INTO AN ADEQUATE POSITION. IT WAS THEN THAT DIFFICULTY WAS EXPERIENCED, AS THE PLASTIC STIFFENER "WOULD NOT RELEASE." THE CATHETER AND STIFFENER WERE REMOVED AS A UNIT AND BOTH THE CATHETER AND THE STIFFENER WERE FLUSHED. THE PHYSICIAN AGAIN ADVANCED THE CATHETER INTO THE CORRECT POSITION AND FOUND THAT THE STIFFENER WAS UNABLE TO BE REMOVED FROM THE CATHETER, EVEN AS FORCE WAS USED. A SECOND CATHETER WAS OPENED AND THOROUGHLY FLUSHED. WHILE ON THE STERILE TABLE, DIFFICULTY WAS EXPERIENCED WHEN ATTEMPTING TO PULL THE STIFFENER FROM THE CATHETER; HOWEVER, IT WAS REPORTED THAT THE STIFFENER WAS ABLE TO BE REMOVED AT THAT TIME. ONCE INSIDE THE PATIENT, THE SECOND DEVICE EXPERIENCED THE SAME FAILURE, AS THE STIFFENER WAS UNABLE TO BE REMOVED FROM THE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14208090 ↗MalfunctionApr 25, 2022Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT A FEMALE PATIENT REQUIRED PLACEMENT OF TWO ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETERS FOR BILATERAL URINARY DIVERSIONS. DURING THE PROCEDURE, THE FLEXIBLE STIFFENERS WERE DIFFICULT TO REMOVE FROM THE CATHETERS AFTER THE DRAINS WERE PLACED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14192743 ↗MalfunctionMay 27, 2020Difficult to Remove; Difficult to Remove
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10093009 ↗MalfunctionMar 16, 2020Difficult to Remove; Difficult to Remove
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED PLACEMENT OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FOR A DRAIN REPLACEMENT PROCEDURE. DURING THE PROCEDURE, THE OPERATOR NOTICED THE STIFFENER COULD NOT BE REMOVED. THE DEVICE WAS REPLACED WITH A NEW DEVICE OF THE SAME LOT AND THE SAME ISSUE OCCURRED. THE DEVICE WAS REPLACED WITH A NEW DEVICE OF A DIFFERENT LOT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9835360 ↗MalfunctionFeb 17, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 9716992 ↗MalfunctionFeb 12, 2020Material Separation; Material Separation
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED THE PLACEMENT OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FOR AN UNKNOWN PROCEDURE. THE OPERATOR REPORTED THAT THE "DRAIN CAME APART DURING THE PROCEDURE." AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9700186 ↗MalfunctionDec 31, 2019Difficult to Remove; Difficult to Remove
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9535649 ↗MalfunctionNov 27, 2019Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9382340 ↗MalfunctionNov 15, 2019Break; Difficult to Remove; Difficult to Advance; Break; Difficult to Remove; Difficult to Advance
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED PLACEMENT OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FOR A NEPHROSTOMY TUBE CHANGE PROCEDURE. AFTER PLACEMENT, THE OPERATOR NOTED "THE BLUE DILATOR GETTING STUCK, HARD TO GET THROUGH AND DIFFICULT TO GET BACK OUT." UPON "RETRIEVAL" OF THE DILATORS, THE SUTURE STRING "SNAPPED". THIS FAILURE OCCURRED ONE MORE TIME WITH ANOTHER DEVICE OF THE SAME LOT. THE DEVICE WAS REPLACED WITH A SIMILAR DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9329880 ↗MalfunctionFeb 27, 2019Difficult to Advance; Difficult to Advance
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8374638 ↗MalfunctionDec 12, 2018Difficult to Remove; Material Separation; Difficult to Remove; Material Separation
IT WAS REPORTED IN ADDITIONAL INFORMATION RECEIVED ON 17DEC2018 THAT THE SCRUB TECH INITIALLY PREPARED THE CATHETER AND THERE WAS NOTHING DIFFERENT THAN NORMAL WHEN THE FLEXIBLE STIFFENER WAS INSERTED. THE CATHETER WAS STRAIGHTENED OUT AND THE STIFFENER INSERTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8157410 ↗MalfunctionApr 24, 2018Difficult to Insert; Difficult to Insert
IT WAS REPORTED DURING A NEPHROSTOMY TUBE EXCHANGE IN THE RIGHT URETER VIA AN ILEAL CONDUIT, THE PLASTIC STIFFENER IN A ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS DIFFICULT TO PUSH THROUGH. ONCE IN THE PATIENT, THE DOCTOR WAS UNABLE TO REMOVE THE STIFFENER. THE DEVICE WAS PULLED FROM THE PATIENT AND A NEW DRAIN WAS PLACED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7456323 ↗InjuryJul 3, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER REPORTED THAT A PATIENT RECEIVED AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER ON (B)(6) 2017 FOR UNSPECIFIED DRAINAGE. THE HUB FELL OFF THE DEVICE ON (B)(6) 2017. THE CIRCUMSTANCES AND HANDLING CONDITIONS LEADING TO THE EVENT ARE NOT KNOWN. THE DEVICE WAS COMPLETELY EXPLANTED AND REPLACED WITH A NEW CATHETER. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.
Patient problems: No Code Available
MAUDE report 6683945 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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