Total Abscession 14000904Recalls & reported problems
Angiodynamics, Inc. · 14F x 40cm Total Abscession Biliary Drainage Catheter (Locking Pigtail) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H787140009040), received between Nov 15, 2018 and Jul 12, 2019 — classified as 2 injuries.
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 18, 2026.
Most reported problems
Device problems
- Crack1
- Detachment of Device or Device Component1
Patient problems
- Device Embedded In Tissue or Plaque2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THE SAME PATIENT HAS HAD MULTIPLE INTERNAL/EXTERNAL BILIARY DRAINAGE CATHETERS DISINTEGRATE. THEY WERE PLACED ON (B)(6) 2018, (B)(6) 2018, (B)(6) 2018, (B)(6) 2019, AND (B)(6) 2019. ALL WERE ANGIODYNAMICS 14FR 40CM BILIARY DRAIN TOTAL ABSCESSION CATHETERS. I ASKED IF THEY WERE USING ANYTHING CORROSIVE TO CLEAN. THE SURGEON SPOKE W/ THE PT. & HER FAMILY AND THEY STATE THAT THEY ARE FLUSHING OUT THE TUBE ONLY W/ SALINE. WHILE THE PT. WENT MORE THAN 4 WEEKS IN BETWEEN CHANGES THIS TIME AROUND, THE SURGEON SAID THAT AT TIMES HE HAS SEEN DETERIORATION IN THE TUBING IN AS LITTLE AS 3 WEEKS IN BETWEEN CHANGES, IN THE PAST. MD ATTEMPTED TO REMOVE AS MANY DRAIN PIECES AS HE COULD. PIGTAIL WAS LEFT IN THE PATIENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8784798 ↗InjuryNov 15, 2018Crack; Crack
CATHETER IMPLANTED (B)(6) 2018. CATHETER EXPLANTED (B)(6) 2018 DUE TO DRAINAGE CATHETER FRACTURING/BREAKING OFF INSIDE THE PATIENT. A FOREIGN BODY REMOVAL WAS THEN PERFORMED. THE DRAINAGE CATHETER WAS REPLACED. NO REPORTED HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8073415 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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