Total Abscession 14000828Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H787140008280), received between Nov 9, 2020 and Nov 9, 2020 — classified as 1 injury.

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 18, 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.

• InjuryNov 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ANGIODYNAMICS RECEIVED A USER MEDWATCH REFERENCE MW5097082. NO IDENTIFYING CUSTOMER/END USER INFORMATION WAS PROVIDED. A LOT HISTORY RECORDS SEARCH FOR THE DRAINAGE CATHETER REVEALED NO QUALITY RELATED ISSUES OR MANUFACTURING DEFICIENCIES AT THE TIME OF MANUFACTURE. THE END USER WHO COMPLETED THE VOLUNTARY EVENT REPORT MW5097082 DID NOT IDENTIFY THEMSELVES. SHIP HISTORY OF THE REPORTED PACKAGING LOT 5553379 WAS SHIPPED TO 14 DIFFERENT END USER FACILITIES. FOLLOW UP COULD NOT BE PERFORMED AS END USER IS STILL UNKNOWN. AN END USER REPORTED AN ISSUE WITH A TOTAL ABSCESSION 10FX30CM PIGTAIL DRAINAGE CATHETER. THE CATHETER SPONTANEOUSLY BROKE INSIDE OF THE PATIENT. THE PIGTAIL CATHETER WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED. NO IDENTIFYING ACCOUNT INFORMATION WAS PROVIDED. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10809595 ↗