Total Abscession 14000804Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H787140008040), received between Oct 2, 2017 and Jul 7, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Crack” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2023Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A TOTAL ABSCESSION DRAINAGE CATHETER 0FX30CM. THE PROVIDER REPORTED THAT LAST WEEK A PATIENT CAME IN WHO HAD A 10FR. ABSCESSION PLACED ON (B)(6), 2023 TO DRAIN AN ABDOMINAL ABSCESS. HE CAME BACK TO US ON (B)(6), 2023 BECAUSE THE CATHETER WAS DRAINING MUCH FLUID BUT THE COLLECTION WAS STILL THERE. THE PROVIDER TYPICALLY JUST SWAPS THE TUBE IN THESE SITUATIONS AND REPOSITION AS NEEDED TO MAKE SURE THE CATHETER IS IN THE AREA MOST BENEFICIAL TO DRAIN. THE PROVIDER PUT THE GUIDEWIRE IN FOR THE EXCHANGE, AND WHEN THE RADIOLOGIST PULLED BACK ON THE TUBE IT SEEMED NORMAL BUT ONLY PART OF THE CATHETER CAME OUT. THE PIGTAIL PORTION WAS STILL IN THE POCKET. IT WAS THOUGHT THE ABSCESS FLUID BROKE DOWN THE INTEGRITY OF THE CATHETER, AND THE PIGTAIL RELEASED BEFORE THEY HAD INSERTED THE GUIDEWIRE. THE RADIOLOGIST INFORMED THE ATTENDING PHYSICIAN THAT THE PIGTAIL PORTION WAS STILL IN THE PATIENT, AND SHE SAID SHE WILL REMOVE IT AT SOME POINT AS THIS PATIENT NEEDS THE ABCESS POCKET CLEANED OUT AS PER NORMAL PROCEDURE. RADIOLOGY DID PLACE ANOTHER TOTAL ABSCESSION DRAINAGE CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 17276820 ↗
• InjuryAug 28, 2018Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON AUGUST 01 2018: PERFORMED CT GUIDED PLACEMENT OF AN 8F PIGTAIL DRAINAGE CATHETER IN A PERIPANCREATIC COLLECTION ON THE EVENING OF (B)(6) 2018 AND CT GUIDED PLACEMENT OF A 10F PIGTAIL DRAINAGE CATHETER IN A LEFT UPPER QUADRANT FLUID COLLECTION ON (B)(6) 2018. THE PATIENT CONTINUED TO DO WELL WHILE IN THE HOSPITAL, AND WAS DISCHARGED HOME ON (B)(6) 2018. PRIOR TO HIS DISCHARGE THE PERIPANCREATIC DRAIN WAS REMOVED, WITH ANTICIPATION OF LEFT UPPER QUADRANT PIGTAIL DRAINAGE CATHETER REMOVAL AS OUTPATIENT. OF NOTE, A CT SCAN OBTAINED ON (B)(6) 2018, DEMONSTRATED BOTH CATHETERS TO BE INTACT. THE LEFT UPPER QUADRANT DRAINAGE CATHETER WAS FUNCTIONING WELL PRIOR TO HIS DISCHARGE, WITH ADEQUATE OUTPUT. THE PATIENT PRESENTED TO THE (B)(6)ER ON (B)(6) 2018 FOR SHORTNESS OF BREATH. A CT SCAN OF THE CHEST WAS OBTAINED WHILE THE PATIENT WAS IN THE ER , WHICH DEMONSTRATED THAT THE LEFT UPPER QUADRANT ABDOMINAL DRAINAGE CATHETER WAS SEVERED, WITH A RETAINED PIGTAIL CATHETER TIP IN THE LEFT UPPER QUADRANT OF THE ABDOMEN (RETAINED FOREIGN BODY). IT WAS REPORTED THE FRAGMENT WAS SUCCESSFULLY REMOVED. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7822155 ↗
• InjuryOct 2, 2017Material Fragmentation; Material Fragmentation

  AS REPORTED TO ANGIODYNAMICS ON SEPTEMBER 09, 2017: A PATIENT HAD A DRAINAGE CATHETER PLACED DURING A SCHEDULED NEPHROSTOMY. THE PATIENT WAS THEN SENT HOME. POST PROCEDURE, THE PATIENT HAD RETURNED TO THE EMERGENCY ROOM WITH COMPLAINTS OF NO URINE OUTPUT. IT WAS REPORTED THAT THE PATIENT'S URINE HAD NOT DRAINED FOR 1-2 DAYS, RESULTING IN SEPTIC PATIENT. ONCE THE CATHETER WAS REMOVED FROM PATIENT, A GUIDE WIRE WAS INSERTED IN THE TUBE AND A SMALL PLASTIC PIECE OF THE CATHETER CAP CAME OUT. A CT SCAN SHOWED HYDRONEPHROSIS. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FEVER, UTI, AND SEPTIC SHOCK. IT WAS REPORTED THE PATIENT SUFFERED NO PERMANENT HARM DUE TO THIS EVENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION UNTIL AFTER THE CUSTOMER'S INTERNAL INVESTIGATION IS COMPLETED.

  Patient problems: Device Embedded In Tissue or Plaque; Fever; Sepsis; Urinary Tract Infection

  MAUDE report 6907228 ↗