Total Abscession 14000806Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H787140008060), received between May 2, 2019 and May 2, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DRAINAGE CATHETER #1- THE PATIENT HAD A14F DRAINAGE CATHETER WITH LOCKING PIGTAIL SUCCESSFULLY PLACED FOR NECROTIC COLLECTION IN PATIENT WITH PANCREATITIS. APPROXIMATELY ONE WEEK AFTER PLACEMENT, IT WAS NOTED THE CATHETER WAS NOT DRAINING AS INTENDED. CT IMAGES CONFIRMED THE PIGTAIL INSIDE THE POCKET AND THE SHAFT HAD DETACHED/BROKEN. IT WAS DETERMINED TO REMOVE THE CATHETER AND REPLACE WITH 2 NEW DRAINAGE CATHETERS. AFTER SOME WEEKS, ONE OF THE NEWLY PLACED CATHETERS DIDN'T PRODUCE AND THE SAME ISSUE OCCURRED, THE PIGTAIL IN THE POCKET AND NO CONNECTION WITH THE SHAFT. (THIS DEVICE WILL BE REPORTED ON MEDWATCH 1319211-2019-00041). THE FRACTURED PIECES WERE NOT RETRIEVED, AND THE PATIENT WAS SCHEDULED FOR A PROCEDURE TO REMOVE THE FRAGMENTS AT A LATER DATE. IT WAS INDICATED THAT THE PIGTAIL TIPS ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8575007 ↗
• InjuryMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DRAINAGE CATHETER #2- THE PATIENT HAD A14F DRAINAGE CATHETER WITH LOCKING PIGTAIL SUCCESSFULLY PLACED FOR NECROTIC COLLECTION IN PATIENT WITH PANCREATITIS. APPROXIMATELY ONE WEEK AFTER PLACEMENT, IT WAS NOTED THE CATHETER WAS NOT DRAINING AS INTENDED. CT IMAGES CONFIRMED THE PIGTAIL INSIDE THE POCKET AND THE SHAFT HAD DETACHED/BROKEN. (THIS DEVICE WILL BE REPORTED ON MEDWATCH 1319211-2019-00040) IT WAS DETERMINED TO REMOVE THE CATHETER AND REPLACE WITH 2 NEW DRAINAGE CATHETERS. AFTER SOME WEEKS, ONE OF THE NEWLY PLACED CATHETERS DIDN'T PRODUCE AND THE SAME ISSUE OCCURRED, THE PIGTAIL IN THE POCKET AND NO CONNECTION WITH THE SHAFT. THE FRACTURED PIECES WERE NOT RETRIEVED, AND THE PATIENT WAS SCHEDULED FOR A PROCEDURE TO REMOVE THE FRAGMENTS AT A LATER DATE. IT WAS INDICATED THAT THE PIGTAIL TIPS ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8575003 ↗