Cook G09641Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002096417), received between Aug 15, 2017 and Jan 20, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 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 9608029 ↗
• MalfunctionFeb 5, 2018Difficult to Remove; Difficult to Remove

  THE INTERNATIONAL CUSTOMER REPORTED THAT, FOLLOWING THE INSERTION OF THE ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER INTO THE PATIENT OVER THE GUIDEWIRE, IT WAS DISCOVERED THAT THE STIFFENER AND THE GUIDEWIRE COULD NOT BE REMOVED; THEY WERE "STUCK". THE EXACT SAME SITUATION OCCURRED A SECOND TIME, FINALLY A THIRD DRAIN WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THE CUSTOMER CONFIRMED THAT NO ADDITIONAL PROCEDURES WERE NECESSITATED BY THE PRODUCT PROBLEM, HOWEVER, THE PATIENT REQUIRED A LONGER THAN USUAL PROCEDURE WITH FLUOROSCOPY TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER, BUT NONE HAS YET BEEN RECEIVED. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7242364 ↗
• MalfunctionJan 24, 2018Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED THAT, DURING A GASTRO-JEJUNAL TUBE INSERTION PROCEDURE, THE SOFT STIFFENER OF THE ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER BECAME STUCK IN THE CATHETER PORTION OF THE DEVICE, AND THE RADIOLOGIST WAS INITIALLY UNABLE TO REMOVE IT POST-INSERTION. HOWEVER, THE DEVICE EVENTUALLY COULD BE REMOVED. UPON REMOVAL, IT WAS NOTED THAT THE STIFFENER APPEARED TO HAVE BUCKLED. A REPEAT DRAINAGE TUBE INSERTION WAS PERFORMED ONCE THE COMPLAINT DEVICE WAS REMOVED. THE DEVICE WAS RECEIVED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7216760 ↗
• MalfunctionNov 1, 2017Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED THAT, WHEN THE ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS REMOVED FROM THE PACKAGING, THE FLEXIBLE STIFFENER COULD NOT BE REMOVED FROM THE PRODUCT. A COMPETITOR'S CATHETER WAS OPENED AND USED TO COMPLETE THE PROCEDURE, WITH NO PATIENT ADVERSE EVENTS REPORTED. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 6993199 ↗
• InjuryAug 15, 2017Material Separation

  THE COMPLAINANT REPORTED THAT THE DRAINAGE CATHETER WAS PLACED FOR A PERIRECTAL ABSCESS AND IT SEPARATED AT THE HUB 6 DAYS AFTER PLACEMENT. THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 6793964 ↗