Porges Coloplast ACXL10Recalls & reported problems
Coloplast A/S · Retrace Ureteral Accesss Sheath 35cm · Class 2
All models of Porges Coloplast (79)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03600040277478), received between Apr 7, 2023 and Apr 7, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Complete Blockage” (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
- Complete Blockage1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2023Complete Blockage; Material Puncture/Hole; Complete Blockage; Material Puncture/Hole
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE TO A DEFECT. THE DEVICE HAD TWO ENTRY HOLES INSTEAD OF ONE. IT WAS NOTED THE OPENINGS WERE CLOSED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16702962 ↗
Other endoscopic access overtube, gastroenterology-urology devices
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- Trokamed WA2PS20STROKAMED GmbH · Endoscopic Access Overtube, Gastroenterology-Urology1 recall2 deaths2 reports
- Trokamed WA2PS20LTROKAMED GmbH · Endoscopic Access Overtube, Gastroenterology-Urology1 recall2 deaths2 reports
- Trokamed WA2PS18LTROKAMED GmbH · Endoscopic Access Overtube, Gastroenterology-Urology1 recall0 reports
- Trokamed WA2PS18STROKAMED GmbH · Endoscopic Access Overtube, Gastroenterology-Urology1 recall0 reports
- Navigator HD M0062502220Boston Scientific Corporation · endoscopic access overtube, gastroenterology-urology1 death31 reports
- Navigator HD M0062502230Boston Scientific Corporation · endoscopic access overtube, gastroenterology-urology29 reports
- Proxis™ Ureteral Access Sheath 231045C. R. Bard, Inc. · endoscopic access overtube, gastroenterology-urology22 reports
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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