Total Abscession 14000803Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H787140008030), received between Nov 5, 2020 and Nov 5, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH A 8FX30 CM TOTAL ABSCESSION DRAINAGE CATHETER. THE FOLLOWING WAS REPORTED: "ON (B)(6) 2020, A PATIENT GET AN 8 F WIRE-LOCKED ABSCESS DRAIN IS INSERTED INTO A LYMPHOCELE ON THE LEFT SIDE NEXT TO THE ILIAC VESSELS (LYMPHOCELE AFTER LYMPH NODE EVACUATION). THE DRAIN SHOULD BE USED BY THE UROLOGIST TO EMPTY THE LYMPHOCYTE AND SCLEROSIS IT WITH ALCOHOL." "ON (B)(6) 2020, TREATMENT IS FINISHED AND THE DRAIN WAS GOING TO BE REMOVED. THE DRAIN WAS CUT NEAR "THE LOCKING HOUSE" AND IN THAT WAY FREE THE LOCK THREAD. A WIRE IS INSERTED AND THE DRAIN IS PULLED OUT, HOWEVER THE TIP OF THE DRAIN COMES LOOSE AND REMAINS, WITH THE LOCKING WIRE REMAINING THROUGH THE TIP. THE DOCTOR WHO PULLED OUT THE DRAIN DID NOT THINK THAT HE HAD TO PULL HARD ON THE DRAIN AT ALL. THE DRAIN TIP IS LEFT TOGETHER WITH THE LOCKING WIRES AND A THIN 4 F CATHETER TO MAINTAIN THE PUNCTURE PATH PRIOR TO EXTRACTION." "ON (B)(6) 2020, THE TIP CAN BE REMOVED WITH A SNARE VIA AN 11 F INTRODUCER. IT WAS A PIECE ABOUT 3 CM LONG." IT WAS REPORTED THE RETAINED TIP WAS SUCCESSFULLY REMOVED WITH NO ADVERSE PATIENT IMPACT. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTU

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10790560 ↗