Cook G09502Recalls & reported problems
Cook Incorporated · Multipurpose Drainage Catheter Ultrathane · Class U · Implant
Quick summary
This is a Cook Ultrathane Mac-Loc multipurpose drainage catheter, placed in the body to drain fluid. Many of the 83 reports describe the hub separating from the catheter shaft, fluid leaking around the locking mechanism, and materials separating or cracking, and a few describe longer procedures. There are 40 injuries and no deaths. 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
- 86
- Deaths reported
- 0
- Injuries reported
- 41
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 00827002095021), received between Apr 6, 2016 and Sep 29, 2026 — classified as 41 injuries, 45 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (22 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
- Fluid/Blood Leak22
- Detachment of Device or Device Component20
- Leak/Splash14
- Material Separation13
- Break5
- Crack4
- Component Falling3
- Obstruction of Flow3
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- No Code Available19
- No Known Impact Or Consequence To Patient16
- Insufficient Information8
- No Consequences Or Impact To Patient4
- Foreign Body In Patient2
- No Patient Involvement2
- Pneumothorax2
Recent adverse event reports
The 25 most recent of 86 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934483 ↗InjurySep 17, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information
MAUDE report 50810002 ↗MalfunctionSep 16, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 50792437 ↗MalfunctionSep 3, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50598537 ↗MalfunctionJul 27, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50037893 ↗MalfunctionJul 27, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50037636 ↗InjuryJun 18, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE HUB OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER DETACHED. THE DEVICE WAS PLACED IN INTERVENTIONAL RADIOLOGY (B)(6) 2026 FOR THE TREATMENT OF A RIGHT PLEURAL EFFUSION IN AN UNKNOWN PATIENT. THE DRAINAGE CATHETER WAS ATTACHED TO A CHEST DRAINAGE SYSTEM AND DRAINED 1100 ML FLUID PRIOR TO BEING CLAMPED. IT WAS NOTED THE FOLLOWING DAY THAT THE HUB HAD DETACHED FROM THE DRAIN, WITH THE SUTURE STRING STILL ATTACHED HOLDING BOTH COMPONENTS TOGETHER. IT WAS SAID THAT THE PATIENT WAS COMPLIANT AND DID NOT APPEAR TO HAVE BEEN MANIPULATING THE TUBE. AT THE TIME OF CUSTOMER REPORT, THE DEVICE REMAINED IN PLACE WHILE THEY AWAITED A POST X-RAY AND RESPIROLOGY/PULMONOLOGY EVALUATION. THE CUSTOMER'S ASSESSMENT OF THE DETACHED HUB NOTED THAT THE CONNECTION BELOW THE LUER LOCK SEEMED LOOSE, POSSIBLY CONTRIBUTING TO THE TUBE BEING DISCONNECTED. THEY TRIED TO REPLICATE THE ISSUE WITH EXPIRED STOCK AND NOTED THAT CONNECTION POINT IS TWISTED ON VERY TIGHTLY AND COULD NOT BE LOOSENED. A CUSTOMER PROVIDED PHOTO OF THE DEVICE SHOWS THE MAC-LOC HUB SEPARATED FROM THE CATHETER SHAFT. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WER
Patient problems: Insufficient Information; Pneumothorax
MAUDE report 25550263 ↗MalfunctionMay 26, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THREE ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETERS WERE UNSEALED AT THE BOTTOM PORTION OF THE PACKAGING. AS REPORTED, A 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 25285103 ↗MalfunctionAug 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IN ADDITIONAL INFORMATION RECEIVED ON 27AUG2025, IT WAS REPORTED THAT THE COMPLAINT DEVICE WAS IN PLACE FOR 5 MINUTES BEFORE THE HUB SEPARATED. THE COMPLAINT DEVICE WAS THEN REMOVED FROM THE PATIENT, AND A NEW CATHETER WAS PLACED TO COMPLETE THE PROCEDURE. THIS LED TO AN INCREASED PROCEDURE TIME, RESULTING IN THE ADMINISTRATION OF MORE CONTRAST AND MORE RADIATION EXPOSURE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22895721 ↗MalfunctionMay 7, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKED FOLLOWING A NEPHROSTOMY TUBE EXCHANGE FOR A PATIENT OF UNKNOWN AGE AND GENDER. UPON SECURING THE MAC-LOC, THE CATHETER WAS FOUND TO BE LEAKING URINE AROUND THE LOCKING MECHANISM. THE CATHETER WAS SUBSEQUENTLY CUT AND REMOVED, AND A NEW CATHETER WAS INSERTED, WHICH HAD NO ISSUES. 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 21977234 ↗MalfunctionMar 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IN ADDITIONAL INFORMATION RECEIVED ON 24APR2025, IT WAS CONFIRMED THAT THE DEVICE WAS INITIALLY PLACED IN TO LEFT PLEURAL EFFUSION BY THE RADIOLOGY STAFF ON (B)(6) 2025. THE DEVICE SEPARATED AT THE HUB, BUT THE TIP OF THE DEVICE REMAINED INTACT, NO FRAGMENTS OF THE COMPLAINT DEVICE WERE LEFT IN THE PATIENT. THE PATIENT HAD LIMITED MOBILITY AND WAS ACUTELY ADMITTED DUE TO COVID AND PLEURAL INFUSION. ADDITIONALLY, THE PATIENT WAS SUFFERING FROM MYOCARDITIS AND WAS UNDERGOING TREATMENT FOR LEUKEMIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21527523 ↗InjurySep 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKED AFTER IT WAS PLACED IN A PATIENT OF UNKNOWN AGE DURING AN UNKNOWN PROCEDURE. THE DRAIN WAS FOUND TO BE LEAKING FROM THE FLOOR AND THE HUB WAS COMPLETELY DISCONNECTED FROM THE CATHETER. THE DEVICE WAS USED AS AN EXTERNAL BILIARY DRAIN. IT WAS NOTED THAT THE DRAIN HAD BEEN EXCHANGED "IN (B)(6)." A NEW DEVICE WAS PLACED IN AN ADDITIONAL PROCEDURE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20292991 ↗MalfunctionAug 15, 2024Material Separation; Obstruction of Flow; Material Separation; Obstruction of Flow
IT WAS REPORTED THAT DURING AN EXCHANGE AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS OCCLUDED. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT 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; No Clinical Signs, Symptoms or Conditions
MAUDE report 19991143 ↗InjuryMay 24, 2024Break; Break
IT WAS REPORTED THE THE SUTURE STRING OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS RETAINED IN THE PATIENT THE CATHETER WAS PLACED FOR USE AS A CHEST DRAIN TO TREAT LEFT EMPYEMA. LATER, DURING REMOVAL OF THE CATHETER, THE MAC-LOC WAS ABLE TO BE UNLOCKED WITH NO ISSUE BY THE REGISTRAR. HOWEVER, THE SUTURE WAS RETAINED IN THE PLEURAL CAVITY. GUIDANCE FROM INTERVENTIONAL RADIOLOGY (IR) REGARDING POTENTIAL REMOVAL HAS BEEN REQUESTED. CURRENTLY, THE SUTURE REMAINS IN THE PATIENT. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: Foreign Body In Patient; Unspecified Mental, Emotional or Behavioral Problem
MAUDE report 19393690 ↗InjuryMay 7, 2024Break; Break
IT WAS REPORTED THAT THE SUTURE STRING OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS RETAINED IN THE PATIENT THE CATHETER WAS PLACED FOR USE AS A CHEST DRAIN TO TREAT LEFT EMPYEMA. LATER, DURING REMOVAL OF THE CATHETER, THE SUTURE WAS RETAINED IN THE PLEURAL CAVITY. GUIDANCE FROM INTERVENTIONAL RADIOLOGY (IR) REGARDING POTENTIAL REMOVAL HAS BEEN REQUESTED. CURRENTLY, THE SUTURE REMAINS IN THE PATIENT. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: Foreign Body In Patient; Unspecified Mental, Emotional or Behavioral Problem
MAUDE report 19260586 ↗MalfunctionJan 19, 2024Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION WAS RECEIVED INDICATING ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE. IT WAS CONFIRMED THAT THE PATIENT DID NO EXPERIENCE ANY NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18545841 ↗InjuryDec 27, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
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 18402228 ↗InjuryJul 25, 2023Material Separation; Detachment of Device or Device Component; Material Separation; 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 17390833 ↗MalfunctionJun 13, 2023Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Fluid Discharge
MAUDE report 17118162 ↗MalfunctionMay 4, 2023Fluid/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 16872855 ↗MalfunctionApr 4, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED A FOREIGN SUBSTANCE WAS FOUND INSIDE THE POUCH OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER PRIOR TO PATIENT CONTACT. NO ADVERSE EFFECTS HAVE BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16676238 ↗InjuryMar 31, 2023Detachment 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 16656703 ↗InjuryMar 31, 2023Detachment 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 16656698 ↗InjuryMar 31, 2023Detachment 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 16656519 ↗InjuryOct 7, 2022Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT AN UNKNOWN PATIENT REQUIRED PLACEMENT OF THE ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER. THE PHYSICIAN OBSERVED AN AIR LEAK IN THE LOCKED CATHETER AFTER PLACEMENT. THE CATHETER WAS REPLACED WITH A NEW LIKE DEVICE IN AN ADDITIONAL PROCEDURE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15566592 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.