Catheter, Cholangiography
FDA adverse event reports and recall history for catheter, cholangiography (product code GBZ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 385
- Deaths
- 2
- Injuries
- 87
- Malfunctions
- 268
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
- 2023-12-02Open, ClassifiedNonconforming Material/Component
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
- 2015-08-05TerminatedEmployee error
Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236
Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter
- 2015-07-22TerminatedProcess control
American Catheter / Cholangiogram Catheter 9100 Series.
Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.
- 2015-07-18TerminatedComponent change control
Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular liver access in diagnostic and interventional procedures. The Ring Transjugular Intrahepatic Access Set consists of the following components: Flexor RTPS Guiding Sheath, needle, catheter, Dilator, Torcon NB Advantage Catheter, Van Andel Dilatation Catheter, Curved Newton Wire Guide, Amplatz Extra Stiff Wire Guide.
Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and the Flexor RTPS Introduce Sheath due to complaints of the dilators being too long.
- 2014-06-12TerminatedEmployee error
Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate the introduction of contrast media into the biliary ducts to obtain a cholangiogram during laparoscopic or open cholecystectomy.
Several complaints were received for the metal support tube missing from the cholangiogram catheter.
- 2008-08-14TerminatedNonconforming Material/Component
HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium Code # 14120, Size (Fr) 20, # Eyelets 5, 10 per case
Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
- 2008-08-14TerminatedNonconforming Material/Component
HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium Code # 14124, Size (Fr) 24, # Eyelets 6, 10 per case
Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
- 2008-08-14TerminatedNonconforming Material/Component
HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium Code # 14132, Size (Fr) 32, # Eyelets 6,
Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
- 2008-08-14TerminatedNonconforming Material/Component
HydraGlide Heparin Coated Silicone Thoracic Catheters - Mediastinal, Eyes on Top & Bottom, Atrium Code # 14509, Size 9mm, # Eyelets 9, 10 per case
Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
- 2008-08-14TerminatedNonconforming Material/Component
HydraGlide Heparin Coated Silicone Thoracic Catheters - Mediastinal, Eyes on Top, Atrium Code # 14709, Size 9mm, # Eyelets 6, 10 per case
Heparin-coated Thoracic Catheters were manufactured with heparin allegedly conminated with oversulfated chondroitin sulfate
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