Endoscopic Access Overtube, Gastroenterology-Urology
FDA adverse event reports and recall history for endoscopic access overtube, gastroenterology-urology (product code FED), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,307
- Deaths
- 22
- Injuries
- 241
- Malfunctions
- 947
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
- 2025-03-21Open, ClassifiedDevice Design
CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.
Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscosity fluid in the kidney, not to continue providing fluid inflow in the presence of unresolved slow or absent fluid outflow because this can create intrarenal pressure imbalance, and lead to excessive intrarenal pressure.
- 2025-01-10Open, ClassifiedLabeling False and Misleading
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
- 2025-01-10Open, ClassifiedLabeling False and Misleading
Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.
If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
- 2025-01-10Open, ClassifiedLabeling False and Misleading
Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
- 2025-01-10Open, ClassifiedLabeling False and Misleading
Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.
If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
- 2013-12-04TerminatedComponent design/selection
Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.
- 2013-12-04TerminatedComponent design/selection
Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.
- 2013-12-04TerminatedComponent design/selection
Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.
- 2007-01-25TerminatedOther
Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL.
Lack of assurance of sterility, as the packages may not have been sealed.
- 2004-07-20TerminatedOther
The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as EndoScrub 2 Sheaths
The sheaths in question have shafts that are one inch longer than required for the endoscope specified on the label.
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