Cook G09504Recalls & reported problems
Cook Incorporated · Multipurpose Drainage Catheter Ultrathane · Class U · Implant
Quick summary
This Cook G09504 Ultrathane multipurpose drainage catheter is used to drain fluid from areas such as the chest or bladder. The 38 reports mostly describe the hub coming loose from the catheter shaft and the material separating or tearing, plus a couple of cases where the catheter broke. Reports mention 16 injuries and no deaths, with most noting no harm to the patient. There are no recalls naming this device, and reports fell from 9 in the prior 12 months to 2 in the last 12 months.
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
- 38
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00827002095045), received between Nov 28, 2016 and Dec 18, 2025 — classified as 16 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (17 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component17
- Material Separation8
- Detachment Of Device Component7
- Break2
- Leak/Splash2
- Component Falling1
- Connection Problem1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Code Available9
- No Known Impact Or Consequence To Patient9
- Insufficient Information5
- No Patient Involvement3
- No Information1
- Pneumothorax1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE HUB OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER DETACHED DURING PRESSURE AREA CARE FOR A PATIENT OF UNKNOWN AGE AND GENDER. THE CATHETER WAS THEN CLAMPED AND REMOVED FROM THE PATIENT. AT THE TIME, NO HARM TO THE PATIENT HAS BEEN REPORTED. A PHOTO PROVIDED BY THE CUSTOMER CONFIRMS DETACHMENT OF THE HUB. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23838665 ↗MalfunctionNov 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
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 23477772 ↗InjuryOct 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
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 23363423 ↗InjurySep 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THERE WERE TWO INSTANCES OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER BREAKING. AT THIS TIME, NO HARM TO THE PATIENT(S) HAS BEEN REPORTED. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22939464 ↗InjuryAug 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
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 22916814 ↗MalfunctionAug 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE HUB OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER DETACHED FROM THE SHAFT WHEN CONNECTING TO CHEST TUBE SUCTION. THE DEVICE WAS PLACED IN CHEST FOR THE DRAINAGE OF THE FLUIDS FROM LUNGS. IT IS UNCLEAR HOW THE PROCEDURE WAS COMPLETED. 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 22895552 ↗MalfunctionJul 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE HUB SEPARATED FROM AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER DURING A SUPRAPUBIC CATHETER EXCHANGE. THE HUB WAS HELD AS THE PLASTIC STIFFENER WAS INSERTED INTO THE CATHETER TO STRAIGHTEN THE PIGTAIL. AT THIS TIME, THE HUB SEPARATED FROM THE CATHETER BODY. A NEW MULTIPURPOSE DRAINAGE CATHETER WAS OPENED TO COMPLETE THE PROCEDURE. 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 22502173 ↗MalfunctionJul 2, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
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 22386244 ↗InjuryMay 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
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 22117128 ↗InjuryNov 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE HUB OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER SEPARATED FOLLOWING PELVIC PLACEMENT IN A PATIENT OF UNSPECIFIED AGE AND GENDER. ON (B)(6) 2024, DURING THE PROCEDURE, THE PHYSICIAN OBSERVED LEAKAGE AT THE CATHETER HUB AND REPLACED IT SUCCESSFULLY WITH ANOTHER LIKE-DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. HOWEVER, 10 DAYS LATER ON (B)(6) 2024, THE PATIENT RETURNED TO THE HOSPITAL DUE TO CATHETER LEAKAGE. ANOTHER PHYSICIAN EXAMINED THE PATIENT AND FOUND THAT THE HUB HAD SEPARATED FROM THE CATHETER. THE COMPLAINT DEVICE WAS REMOVED AND REPLACED WITH A NEW LIKE-DEVICE IN AN ADDITIONAL PROCEDURE. THE USER NOTED THAT NO FORCE WAS EXERTED ON THE CATHETER, AS IT WAS USED NORMALLY. A PHOTO PROVIDED BY THE CUSTOMER CONFIRMS THE CATHETER HUB SEPARATION. THIS REPORT CAPTURES HUB SEPARATION THAT OCCURRED ON (B)(6) 2024. THE INSTANCE OF HUB LEAKAGE THAT OCCURRED ON (B)(6) 2024 IS CAPTURED IN THE REPORT WITH PATIENT IDENTIFIER (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20589890 ↗MalfunctionNov 1, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED THAT AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKED WHERE THE CATHETER MET THE HUB DURING AN UNSPECIFIED PROCEDURE ON A PATIENT OF UNSPECIFIED AGE AND GENDER. ON (B)(6) 2024, DURING THE PROCEDURE, THE PHYSICIAN OBSERVED LEAKAGE AT THE CATHETER HUB AND REPLACED IT SUCCESSFULLY WITH ANOTHER LIKE-DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. HOWEVER, 10 DAYS LATER ON (B)(6) 2024, THE PATIENT RETURNED TO THE HOSPITAL DUE TO CATHETER LEAKAGE. ANOTHER PHYSICIAN EXAMINED THE PATIENT AND FOUND THAT THE HUB HAD SEPARATED FROM THE CATHETER. THE COMPLAINT DEVICE WAS REMOVED AND REPLACED WITH A NEW LIKE-DEVICE IN AN ADDITIONAL PROCEDURE. THE USER NOTED THAT NO FORCE WAS EXERTED ON THE CATHETER, AS IT WAS USED NORMALLY. THE DRAIN WAS PLACED IN THE PELVIS. THIS REPORT CAPTURES HUB LEAKAGE THAT OCCURRED ON (B)(6) 2024. THE INSTANCE OF HUB SEPARATION THAT OCCURRED ON (B)(6) 2024 IS CAPTURED IN THE REPORT WITH PATIENT IDENTIFIER (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20589575 ↗MalfunctionAug 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE HUB OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER SEPARATED FROM THE CATHETER SHAFT. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. IT HAS NOT BEEN CONFIRMED IF AND HOW THE PROCEDURE WAS COMPLETED. 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 20090472 ↗MalfunctionJan 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
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 18519951 ↗InjuryAug 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A PATIENT REQUIRED REPLACEMENT OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER. IT WAS NOTED AT AN UNKNOWN TIME POST PLACEMENT, THE HUB WAS SEPARATED FROM THE CATHETER, NOT ALLOWING CHEST TUBE TO SUCTION PROPERLY. THE PATIENT RETURNED TO INTERVENTIONAL RADIOLOGY FOR DEVICE EXCHANGE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15245528 ↗InjuryJul 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ADDITIONAL INFORMATION PROVIDED 11AUG2021 STATED THE PATIENT REQUIRED REPLACEMENT OF THE DRAIN. NO OTHER ADVERSE EFFECTS WERE REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12130208 ↗MalfunctionApr 30, 2021Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component
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 11757357 ↗MalfunctionFeb 17, 2020Material Separation; Material Separation
IT WAS REPORTED A (B)(6) FEMALE PATIENT REQUIRED THE PLACEMENT OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FOR A PANCREAS ABSCESS DRAINAGE PROCEDURE. THE OPERATOR REPORTED IMMEDIATELY AFTER THE DRAIN WAS PLACED, THE NURSE WAS SECURING THE DEVICE WITH THE STAT-LOCK WHEN "THE PLASTIC MAC-LOCK DISCONNECTED FROM THE CATHETER, AND THE DRAIN FELL OUT." ANOTHER SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9717009 ↗MalfunctionOct 29, 2018Connection Problem; Connection Problem
IT WAS REPORTED AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS PLACED FOR AN UNSPECIFIED DRAINAGE PROCEDURE. WHEN DRAWING THE FLUID DURING THE PROCEDURE, AIR WAS DISCOVERED TO BE DRAWING AS WELL. IT IS UNKNOWN WHETHER THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. ALTHOUGH REQUESTED, ADDITIONAL DETAILS REGARDING THE EVENT, PATIENT OUTCOME AND DEVICE RETURN ARE UNAVAILABLE.
Patient problems: No Information
MAUDE report 8015607 ↗InjuryMay 10, 2018Material Separation; Material Separation
IT WAS REPORTED DURING CHEST TUBE PLACEMENT THE HUB ON A ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER BROKE OFF. FOR REPLACEMENT, THE 14FR DRAIN WAS REMOVED OVER A WIRE AND A 16FR DRAIN WAS PLACED OVER THE WIRE. 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 7503675 ↗MalfunctionMay 7, 2018Material Separation; Material Separation
IT WAS REPORTED THAT THE USER FACILITY EXPERIENCED HUBS DETACHING FROM ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETERS. THIS MEDWATCH REPORT ADDRESSES SIXTEEN UNUSED DEVICES THE FACILITY RETURNED FOR EVALUATION.
Patient problems: No Patient Involvement
MAUDE report 7489822 ↗MalfunctionApr 26, 2018Material Separation; Material Separation
DUE TO PRIOR EVENTS (PR223340- HUB DETACHED), THE USER DECIDED TO TEST THE HUBS BEFORE USE. TWO DEVICE WERE TUGGED AND THE HUBS DETACHED. THE USER PULLED THIS ENTIRE LOT FROM THEIR SHELF TO RETURN TO COOK AS THEY ARE NOT TRUSTED.
Patient problems: No Patient Involvement
MAUDE report 7464123 ↗MalfunctionApr 26, 2018Material Separation; Material Separation
IT WAS REPORTED AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS USED FOR RIGHT CHEST ABSCESS DRAINAGE WHEN THE HUB DETACHED LESS THAN 24 HOURS AFTER PLACEMENT. THE DEVICE WAS REMOVED AND ANOTHER LIKE DEVICE WAS USED. THE USER FACILITY PERFORMED A TUG TEST ON TWO UNOPENED AND UNUSED DEVICES FROM THE SAME LOT TO ASSURE THERE WAS NO ISSUE. ONE OF THE TESTED DEVICES PASSED AND ONE FAILED. THE REPORTED USED DEVICE WILL NOT BE RETURNED, HOWEVER, BOTH UNUSED DEVICES WILL BE RETURNED FOR EVALUATION.
Patient problems: No Code Available
MAUDE report 7464060 ↗MalfunctionAug 16, 2017Material Separation
THE HUB OF THE FIRST DEVICE SEPARATED FROM THE CATHETER NINE DAYS AFTER PLACEMENT WITHIN THE (B)(6) FEMALE PATIENT (MFR# 1820334-2017-02644). THE PATIENT CAME BACK TO THE HOSPITAL FOR ANOTHER PLACEMENT PROCEDURE. THE CATHETER THAT WAS INITIALLY GOING TO BE USED FOR REPLACEMENT SEPARATED FROM THE HUB BEFORE IT MADE PATIENT CONTACT (THIS REPORT). THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. THERE WERE NO INJURIES OR ADDITIONAL MEDICAL PROCEDURES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6797897 ↗MalfunctionAug 16, 2017Detachment Of Device Component
THE COMPLAINANT REPORTED THAT THE HUB DETACHED UPON TESTING BY A "TUG TEST." THIS WAS DONE PRIOR TO USE SO NO PATIENT HARM WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6797097 ↗MalfunctionAug 16, 2017Detachment Of Device Component
DURING PLACEMENT OF THE DEVICE AS AN ABSCESS DRAIN, THE HUB CAME APART FROM TWO CATHETERS. THE PHYSICIAN PLACED ANOTHER DEVICE OF A DIFFERENT SIZE. 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 Known Impact Or Consequence To Patient
MAUDE report 6796958 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.