Dornier HOOVER Access Sheath IVX-NS-1050Recalls & reported problems
Dornier Medtech America, Inc. · Hoover Negative Pressure Ureteral Access Sheath, 10Fr x 50 cm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810116023615), received between May 18, 2026 and May 18, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Insert” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Insert1
- Improper or Incorrect Procedure or Method1
Patient problems
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2026Difficult to Insert; Improper or Incorrect Procedure or Method
A DISTRIBUTOR EMAILED DMTA AND STATED: "THE DOCTOR SAID HE PROCEEDED TO PLACE THE ACCESS SHEETS WITH THE INTRODUCER OVER THE WIRE AND THE INTRODUCER PUNCTURED THE URETER. ONCE THE DOCTOR RECOGNIZED WHAT TOOK PLACE, HE HAD TO PLACE A STENT AND ABANDONED THE CASE." THE PATIENT HAD THE STENT PLACED AND WAS SENT HOME.
Patient problems: Perforation
MAUDE report 25209738 ↗
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- 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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