Dawson Mueller G13768Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00827002137684), received between Nov 3, 2016 and Sep 29, 2026 — classified as 9 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Difficult to Remove

  It was reported that the stiffening cannula could not be removed from an Ultrathane Dawson-Mueller Mac-Loc Locking Loop Multipurpose Drainage Catheter during an unspecified procedure.The drainage catheter with stiffener were advanced over the wire guide; however, when attempting to remove the stiffening cannula, it was found to be firmly lodged in the catheter and could not be removed. Another device was subsequently used, but the stiffening cannula of that device also could not be removed. The procedure was completed using an alternative like device from a different catalog number.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 50935629 ↗
• MalfunctionJul 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE HUB OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKED AIR/FLUID. THE USER DISCONTINUED ITS USE AND COMPLETED THE PROCEDURE WITH ANOTHER DEVICE FROM HOSPITAL STOCK. 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 25720286 ↗
• MalfunctionJul 1, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE HUB OF AN ULTRATHANE DAWSON MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKED. THE LEAKAGE WAS NOTED AFTER PLACEMENT. THEREFORE, THE LEAKING DRAINAGE CATHETER WAS REMOVED, AND A NEW DRAINAGE CATHETER WAS INSERTED BEFORE COMPLETION OF THE PROCEDURE. THE PHYSICIAN CUT OFF THE CATHETER SHAFT OF THE DEVICE AND DISCARDED, ONLY LEAVING THE HUB OF THE DEVICE FOR EVALUATION. 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 25681394 ↗
• MalfunctionJun 18, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS DAMAGED. THE DEVICE HAD PLANNED TO BE USED FOR A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE. HOWEVER, WHEN ATTEMPTING TO PLACE THE DEVICE AFTER INSERTING THE TROCAR, A POSSIBLE CRACK WAS OBSERVED AT THE DISTAL TIP OF THE CATHETER. THEREFORE, THE DEVICE WAS NOT USED, AND THE PROCEDURE WAS COMPLETED USING AN UNSPECIFIED 8.5 FR DRAINAGE CATHETER. THE USER COMMENTED THAT THE TIMING OF THE CRACK OCCURRENCE IS UNKNOWN, POSSIBLY OCCURRING WHEN THE ASSISTANT INSERTED THE TROCAR. HOWEVER, IT DID NOT APPEAR BY THE USER TO BE CONSISTENT WITH TYPICAL DAMAGE CAUSED DURING SUCH HANDLING. 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 25551558 ↗
• MalfunctionOct 28, 2025Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT THE HUB OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKED. THE DEVICE WAS REQUIRED FOR PERCUTANEOUS DRAINAGE OF THE BILE DUCT IN A MALE PATIENT. AFTER PLACEMENT OF THE DRAINAGE CATHETER, ASPIRATION WAS ATTEMPTED USING A SYRINGE. HOWEVER, DRAINAGE WAS UNSUCCESSFUL, AND AIR WAS OBSERVED ENTERING THE SYRINGE. EVEN AFTER CONNECTING A DRAINAGE BAG, DRAINAGE COULD NOT BE ACHIEVED. TO ADDRESS THIS ISSUE, THE CONNECTION BETWEEN THE DRAINAGE BAG AND THE HUB OF THE DRAINAGE CATHETER WAS WRAPPED WITH TAPE, WHICH ELIMINATED AIR ENTRY. THE CATHETER WAS USED UNTIL THE PATIENT WAS DISCHARGED. 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 23407154 ↗
• MalfunctionAug 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22912989 ↗
• InjuryFeb 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HUB OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER SEPARATED FOLLOWING PLACEMENT VIA PERCUTANEOUS ABDOMINAL APPROACH IN A 16-YEAR-OLD MALE PATIENT. THE CATHETER WAS INITIALLY USED FOR THE DRAINAGE OF AN ABSCESS, WITH NO LEAKAGE OBSERVED DURING THE PROCEDURE AND THE DEVICE REMAINED IN PLACE FOR 5-6 HOURS. HOWEVER, LEAKAGE OF THE BODY FLUIDS WAS NOTED THE FOLLOWING NIGHT, AND UPON INSPECTION, IT WAS CONFIRMED THAT THE HUB HAD SEPARATED FROM THE CATHETER. THE CATHETER WAS CONNECTED TO A DRAINAGE BAG AT THE TIME OF FAILURE. THE DEVICE WAS SECURELY TAPED IN PLACE OVERNIGHT AND SUBSEQUENTLY REPLACED WITH A NEW LIKE-DEVICE THE FOLLOWING DAY IN AN ADDITIONAL PROCEDURE. THERE WAS NO DAMAGE NOTED TO THE DEVICE PRIOR TO USE. THE DEVICE WAS STORED UPRIGHT AND REMAINED INTACT DURING THE PROCEDURE. AS PER THE PHYSICIAN, IT IS UNLIKELY THAT THE PATIENT, WHO HAD SOME DISABILITIES, CAUSED THE DISCONNECTION THROUGH PULLING ON THE CATHETER. THE CATHETER PROTRUDING LESS THAN 10 CM FROM THE BODY FURTHER SUGGESTS THAT PULLING BY THE PATIENT IS NOT A PROBABLE CAUSE OF THE FAILURE, AS IT WOULD LIKELY HAVE RESULTED IN THE ENTIRE CATHETER BEING D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21425633 ↗
• InjuryDec 13, 2023Break; Break

  IT WAS REPORTED THAT THE SUTURE STRING OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER SEPARATED. THE DEVICE WAS PLACED IN THE LIVER ON (B)(6) 2023 FOR ABSCESS DRAINAGE. ONE WEEK LATER, REPOSITIONING OF THE CATHETER WAS ATTEMPTED. A WIRE GUIDE WAS INSERTED INTO THE CATHETER, BUT THE PIGTAIL WOULD NOT STRAIGHTEN. THE POSITION ADJUSTMENT WAS COMPLETED WITH THE CATHETER AS IT WAS. ON (B)(6) 2023, RESISTANCE WAS EXPERIENCED DURING CATHETER REMOVAL. THE CATHETER WAS PULLED AND REMOVED; HOWEVER, THE SUTURE WAS RETAINED IN THE PATIENT. A SHEATH AND SNARE WERE OBTAINED TO RETRIEVE THE SUTURE, BUT THE PATIENT COMPLAINED OF PAIN, SO THE PROCEDURE WAS COMPLETED, AND THE SUTURE REMAINED IN THE PATIENT. ON (B)(6) 2023, AN ADDITIONAL SURGERY WAS PERFORMED TO REMOVED THE SUTURE LAPAROSCOPICALLY. AS REPORTED, A PORTION OF THE SUTURE LIKELY REMAINS IN THE LIVER. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18317601 ↗
• MalfunctionAug 24, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE METAL STIFFENING CANNULA WAS DIFFICULT TO REMOVED FROM AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER. THE DEVICE WAS REQUIRED TO DRAIN BILE DURING A PERCUTANEOUS TRANSHEPATIC GALLBLADDER DRAINAGE (PTGBD) PROCEDURE. THE DEVICE WAS PLACED VIA SELDINGER TECHNIQUE, THEN THE USER ATTEMPTED TO REMOVED THE CANNULA BUT IT WAS STUCK IN THE CATHETER. THE CATHETER AND CANNULA WERE REMOVED FROM THE PATIENT AS A UNIT AND AN ADDITIONAL LIKE-DEVICE WAS OBTAINED; HOWEVER THE SAME FAILURE OCCURRED. FINALLY, A THIRD 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 FIRST FAILED CATHETER IS REPORTED UNDER PATIENT IDENTIFIER (B)(6). THE SECOND FAILED CATHETER IS REPORTED UNDER PATIENT IDENTIFIER (B)(6) (THIS REPORT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15283744 ↗
• MalfunctionAug 23, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE METAL STIFFENING CANNULA FROM AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS DIFFICULT TO REMOVE. THE DEVICE WAS BEING PLACED FOR PERCUTANEOUS TRANSHEPATIC GALLBLADDER DRAINAGE (PTGBD). THE CATHETER AND STIFFENER COMBINATION WERE ADVANCED INTO THE TARGET SITE VIA SELDINGER TECHNIQUE, HOWEVER, WHEN TRYING TO REMOVE THE CANNULA FROM THE CATHETER, IT COULD NOT BE REMOVED. THE CATHETER AND STIFFENER COMBINATION WERE REMOVED. ANOTHER, SIMILAR DEVICE WAS ADVANCED, BUT THE SAME ISSUE WAS OBSERVED. A THIRD DEVICE WAS PLACED SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES. THE FIRST FAILED CATHETER IS REPORTED UNDER PATIENT IDENTIFIER (B)(6) (THIS REPORT). THE SECOND FAILED CATHETER IS REPORTED UNDER PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15279061 ↗
• MalfunctionJun 15, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKED BETWEEN THE HUB AND THE TUBING. 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 14694989 ↗
• MalfunctionDec 3, 2021Fluid/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 12924418 ↗
• MalfunctionDec 3, 2021Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; 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 12923394 ↗
• MalfunctionNov 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FOR BILIARY DRAINAGE. AFTER PLACING THE DRAINAGE CATHETER USING ABDOMINAL APPROACH, LEAKAGE WAS NOTED BETWEEN THE HUB AND THE CATHETER. DAMAGE WAS ALSO NOTED AT THE SAME LOCATION. THE FAULTY DRAIN WAS REMOVED AND REPLACED WITH ANOTHER DEVICE OF THE SAME LOT SUCCESSFULLY. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12900259 ↗
• MalfunctionNov 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FOR GALLBLADDER DRAINAGE. THE CATHETER WAS ADVANCED INTO THE TARGET SITE VIA ABDOMINAL APPROACH AND THE PHYSICIAN ATTEMPTED TO EXTRACT BILE. NO DRAINAGE OCCURRED. AN X-RAY EXAMINATION WAS CONDUCTED TO CONFIRM THE CATHETER TIP WAS PROPERLY POSITIONED. UPON INFUSION OF CONTRAST, LEAKAGE WAS NOTED AT "DAMAGE" AT 3-4 CM FROM THE HUB OF THE CATHETER. THE CATHETER WAS CUT AND REMOVED FROM THE PATIENT. A SIMILAR DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12886727 ↗
• MalfunctionMar 18, 2021Difficult to Remove; Difficult to Remove

  ADDITIONAL INFORMATION PROVIDED ON 22MAR2021 STATED THAT THE DIFFICULTY WAS WITH THE METAL STIFFENING CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11519759 ↗
• MalfunctionFeb 19, 2021Failure to Advance; Failure to Advance

  NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11349585 ↗
• InjuryOct 2, 2020Leak/Splash; Material Separation; Leak/Splash; Material Separation

  ADDITIONAL INFORMATION RECEIVED 16OCT2020 STATING THE DEVICE WAS INSERTED FROM THE RIGHT INTERCOSTAL AND PLACED IN THE GALLBLADDER IN ORDER TO TREAT CHOLECYSTITIS BY DRAINING THE INFECTED BILE. A LEAK WAS NOTED BETWEEN THE HUB AND THE CATHETER.

  Patient problems: No Code Available

  MAUDE report 10619596 ↗
• MalfunctionAug 20, 2020Fluid/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 Known Impact Or Consequence To Patient

  MAUDE report 10434344 ↗
• MalfunctionAug 20, 2020Fluid/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 Known Impact Or Consequence To Patient

  MAUDE report 10434289 ↗
• MalfunctionJul 7, 2020Gas/Air Leak; Gas/Air Leak

  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 10240979 ↗
• InjurySep 16, 2019Material Separation; Material Separation

  IT WAS REPORTED A ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS USED IN A PATIENT FOR AN UNKNOWN PROCEDURE. THE CATHETER WAS PLACED SUCCESSFULLY. NINE DAYS LATER, THE OPERATOR NOTED SEPARATION OF THE CATHETER FROM THE HUB. THE DEVICE WAS REMOVED AND REPLACED WITH A SIMILAR DEVICE OF A DIFFERENT MANUFACTURER. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Code Available

  MAUDE report 9072639 ↗
• MalfunctionSep 10, 2019Unsealed Device Packaging; Unsealed Device Packaging

  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; No Patient Involvement

  MAUDE report 8984060 ↗
• MalfunctionAug 5, 2019Leak/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 Known Impact Or Consequence To Patient

  MAUDE report 8859236 ↗
• MalfunctionApr 11, 2019Fracture; Fracture

  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 8503103 ↗