Cook G09501Recalls & reported problems
Cook Incorporated · Multipurpose Drainage Catheter Ultrathane · Class U · Implant
Quick summary
This Cook Ultrathane multipurpose drainage catheter is a tube used to drain fluid from the body. The 281 reports often describe fluid leaks, parts separating or breaking, and catheters that are hard to advance or remove. The reports include no deaths and 106 injuries. No recalls name this device, and reports fell to 6 in the last year from 15 in the year before.
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
- 280
- Deaths reported
- 0
- Injuries reported
- 106
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 280 adverse event reports that list this exact device (DI 00827002095014), received between Feb 2, 2015 and Jul 27, 2026 — classified as 106 injuries, 174 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (90 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
- Leak/Splash90
- Fluid/Blood Leak59
- Material Separation37
- Break28
- Difficult to Remove23
- Detachment Of Device Component17
- Detachment of Device or Device Component17
- Disconnection6
Patient problems
- No Code Available82
- No Known Impact Or Consequence To Patient81
- No Clinical Signs, Symptoms or Conditions75
- No Consequences Or Impact To Patient18
- No Patient Involvement10
- Foreign Body In Patient6
- No Information4
- Insufficient Information3
Recent adverse event reports
The 25 most recent of 280 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50043062 ↗MalfunctionJun 17, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT A TEAR IN A DISTAL SIDE HOLE OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS IDENTIFIED WHILE FLUSHING WITH SALINE PRIOR TO USE. 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 25535862 ↗MalfunctionJun 12, 2026Material Separation
IT WAS REPORTED THAT AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS DIFFICULT TO ADVANCE AND SEPARATED. DURING A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTCD) PROCEDURE, AFTER ROUTINE FLUSHING OF THE PRODUCT, IT WAS FOUND THAT THE TIP OF THE DRAINAGE CATHETER WAS ROUGH AND DIFFICULT TO ENTER THE PATIENT. DURING THE PROCESS OF ADVANCING THE CATHETER, METAL SUPPORTS WITHOUT MATCHING PACKAGING WERE USED TOGETHER FOR ADVANCEMENT. AFTER MULTIPLE ATTEMPTS, THE MIDDLE POSITION OF THE CATHETER BROKE, AND THE SUTURE FELL OFF, MAKING IT UNUSABLE. THEREFORE, A NEW DRAINAGE CATHETER WAS OBTAINED TO CONTINUE 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 25487908 ↗MalfunctionDec 9, 2025Difficult 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 Clinical Signs, Symptoms or Conditions
MAUDE report 23760891 ↗MalfunctionNov 12, 2025Difficult 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 Clinical Signs, Symptoms or Conditions
MAUDE report 23534316 ↗InjuryAug 26, 2025Break; Obstruction of Flow; Break; Obstruction of Flow
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 22895419 ↗MalfunctionAug 20, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE METAL STIFFENING CANNULA WAS DIFFICULT TO REMOVE FROM THE ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER. DURING A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTCD) PROCEDURE, THE CANNULA WAS DIFFICULT TO ADVANCE. ONCE THE CANNULA WAS ADVANCED, IT BECAME LODGED IN THE CATHETER AND COULD NOT BE REMOVED. THE DEVICE COMPONENTS WERE REMOVED TOGETHER, AND A NEW LIKE DEVICE WAS USED 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 22855811 ↗MalfunctionAug 13, 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 22797965 ↗InjuryAug 13, 2025Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
IT WAS REPORTED THAT THE HUBS OF TWO ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETERS SEPARATED FOLLOWING PLACEMENT IN A UNKNOWN PATIENT. IT WAS CONFIRMED THAT THE HUB SEPARATIONS DID NOT OCCUR ON THE SAME DAY. ONE DEVICE WAS IN PLACE FOR 2 DAYS BEFORE THE HUB DETACHED, WHILE THE INDWELLING TIME FOR THE SECOND DEVICE BEFORE HUB DETACHMENT IS UNKNOWN. IN BOTH INSTANCES, THE CATHETERS HAD TO BE REMOVED AND REPLACED IN AN ADDITIONAL PROCEDURE. NO ADDITIONAL HARM TO THE PATIENT HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22797175 ↗MalfunctionJul 29, 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 22647133 ↗MalfunctionApr 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKED. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE TWO UNKNOWN PATIENTS WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information
MAUDE report 21858420 ↗MalfunctionMar 31, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE METAL STIFFENING CANNULA WAS DIFFICULT TO REMOVE FROM AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER. DURING THE PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTCD) PROCEDURE, AFTER THE DRAINAGE CATHETER WAS PLACED INTO THE PATIENT, THE OPERATOR FOUND THAT THE CANNULA COULD NOT BE REMOVED FROM THE CATHETER. AFTER SEVERAL ATTEMPTS, THE DRAINAGE CATHETER AND THE CANNULA WERE WITHDRAWN TOGETHER. A NEW DRAINAGE CATHETER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE USER NOTED THAT THE PUNCTURE NEEDLE WAS ABLE TO BE REMOVED FROM THE STIFFENING CANNULA. 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 21733927 ↗MalfunctionMar 26, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21700220 ↗MalfunctionMar 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE HUB OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS FOUND TO BE LEAKING FOLLOWING AN ASCITIC TAP PROCEDURE FOR A PATIENT OF UNKNOWN AGE AND GENDER. ON (B)(6)2025, A PATIENT UNDERWENT AN ASCITIC TAP PROCEDURE IN THE DEPARTMENT OF SURGICAL ADMISSIONS (DOSA). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT COMPLICATIONS, AND THE PATIENT WAS SUBSEQUENTLY RETURNED TO DOSA FOR POST-PROCEDURE DRAINAGE MONITORING AND MANAGEMENT, AS PER STANDARD OUTPATIENT PROTOCOL. THE DRAIN WAS INSERTED BY THE CUSTOMER IN THE RADIOLOGY DEPARTMENT AND WAS CONFIRMED TO BE IN SITU, FUNCTIONING CORRECTLY, AND DRAINING EFFECTIVELY WITHOUT ANY SIGNS OF LEAKAGE AT THE TIME OF DEPARTURE. HOWEVER, LATER THAT DAY, AT APPROXIMATELY 16:00, THE CUSTOMER WAS CONTACTED BY RECEPTION AND ADVISED TO CALL DOSA REGARDING AN ISSUE WITH THE DRAIN. UPON CONTACTING DOSA, THE CUSTOMER SPOKE WITH A NURSE WHO REPORTED THAT LEAKAGE HAD OCCURRED FROM THE LOCKING MECHANISM WHEN THE DRAIN WAS UNLOCKED FOR REMOVAL. THE NURSE INDICATED THAT A SIGNIFICANT VOLUME OF FLUID HAD LEAKED, SATURATING TWO ABSORBENT PADS ("BLUEYS") AND CAUSING FURTHER SPILLAGE. A DISCUSSION WAS DONE TO IDENTIFY TH
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21516719 ↗MalfunctionFeb 24, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS LEAKING. DURING A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE PROCEDURE FOR A 57-YEAR-OLD FEMALE PATIENT, THE DRAINAGE CATHETER WAS PLACED ACCORDING TO THE APPROPRIATE STEPS. WHEN ACCESSING THE DRAINAGE BAG, A LEAK WAS NOTED AT THE MAC-LOC HUB PORTION OF THE DRAINAGE CATHETER. THE PROCEDURE WAS COMPLETED BY REPLACING THE DRAINAGE CATHETER WITH A NEW DEVICE. 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 21452304 ↗MalfunctionDec 10, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT LEAKAGE WAS IDENTIFIED AT THE HUB OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER DURING AN UNKNOWN PROCEDURE. A NEW LIKE-DEVICE WAS OPENED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. A VIDEO PROVIDED BY THE CUSTOMER SHOWED LEAKAGE COMING FROM THE CAP OF THE MAC-LOC HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20895025 ↗MalfunctionNov 27, 2024Fluid/Blood Leak; Fluid/Blood Leak
IN ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024, IT WAS REPORTED THAT LEAKAGE WAS NOT DISCOVERED WHEN FLUSHING PRIOR TO USE. A NEW DRAIN WAS USED TO COMPLETE THE PROCEDURE. AN EXACT DATE OF EVENT CANNOT BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20799107 ↗MalfunctionNov 27, 2024Fluid/Blood Leak; Fluid/Blood Leak
IN ADDITIONAL INFORMATION RECEIVED ON 04DEC2024, IT WAS REPORTED THAT LEAKAGE WAS NOT DISCOVERED WHEN FLUSHING PRIOR TO USE. A NEW DRAIN WAS USED TO COMPLETE THE PROCEDURE. AN EXACT DATE OF EVENT CANNOT BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20799085 ↗MalfunctionNov 19, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKED FOLLOWING PERCUTANEOUS HEPATIC DRAINAGE AND INSERTION IN A PATIENT OF UNKNOWN AGE AND GENDER. DURING THE PROCEDURE, BILE WAS FOUND TO BE LEAKING FROM THE MIDDLE PORTION OF THE DRAINAGE CATHETER HUB. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING A NEW LIKE DEVICE. THE PHOTO PROVIDED BY THE CUSTOMER CONFIRMS LEAKAGE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20724663 ↗MalfunctionNov 15, 2024Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER PACKAGE WAS FOUND TO BE UNSEALED PRIOR TO THE USE OF DRAINAGE CATHETER. A NEW LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PHOTO PROVIDED BY THE CUSTOMER CONFIRMS OPEN PACKAGE SEALS WITHOUT EVIDENCE OF ADHESIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20695409 ↗MalfunctionOct 24, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE STIFFENING CANNULA OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS DIFFICULT TO REMOVE FOLLOWING INSERTION INTO A 64-YEAR-OLD FEMALE PATIENT DURING AN UNKNOWN PROCEDURE. THE CUSTOMER NOTED THAT THE CATHETER APPEARED TO BE RETRACTED AND FOLDED. AS A RESULT, THE CATHETER COULDN¿T ENTER COMPLETELY AND WAS REMOVED. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. A VIDEO PROVIDED BY THE CUSTOMER CONFIRMS THE DEVICE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20524154 ↗InjuryOct 18, 2024Break; Break
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient
MAUDE report 20487286 ↗MalfunctionOct 1, 2024Fluid/Blood Leak; Fluid/Blood Leak
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 20345260 ↗InjurySep 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE DEVICE WAS PLACED IN A 62-YEAR-FEMALE FOR USE AS A NEPHROSTOMY TUBE. A FEW HOURS AFTER PLACEMENT, IT WAS DISCOVERED THAT THE CATHETER HAD BEEN ¿PULLED¿, AND THE HUB WAS SEPARATED FROM THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20148599 ↗MalfunctionAug 23, 2024Leak/Splash; Leak/Splash
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 20053774 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.