Stents, Drains And Dilators For The Biliary Ducts
FDA adverse event reports and recall history for stents, drains and dilators for the biliary ducts (product code FGE), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 33,442
- Deaths
- 359
- Injuries
- 9,757
- Malfunctions
- 23,022
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-07-01Open, ClassifiedPackage design/selection
CRE Pro Wireguided 6-8mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-01Open, ClassifiedPackage design/selection
CRE Pro Wireguided 8-10mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-01Open, ClassifiedPackage design/selection
CRE Pro Wireguided 10-12mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-01Open, ClassifiedPackage design/selection
CRE Pro Wireguided 12-15mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-01Open, ClassifiedPackage design/selection
CRE Pro Wireguided 15-18mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-01Open, ClassifiedPackage design/selection
CRE Pro Wireguided 18-20mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-04-06Open, ClassifiedIncorrect or no expiration date
COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 2025-09-23Open, ClassifiedProcess control
Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
- 2024-10-25Open, ClassifiedUnder Investigation by firm
EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy. Model/Catalog Number: BD-410X-1055
Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surgery. All other labeling is correct for the balloon, including the Shelf Box with Front Box Label and Circular Star Label and the balloon Pouch
- 2024-06-27Open, ClassifiedLabeling Change Control
Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique. ORDER NUMBER: GPN: G09230
Product labels state the incorrect expiration dates that extends beyond their true expiration date
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