BladderScan® BVI 9400 (REF 0400-0066)Recalls & reported problems
Verathon Inc · Class 2
Data updated Oct 16, 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 00879123002259), received between Oct 25, 2018 and Oct 25, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Explosion” (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 16, 2026.
Most reported problems
Device problems
- Explosion1
- Fire1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 25, 2018Fire; Explosion; Fire; Explosion
IT WAS REPORTED BY THE (B)(6) SAFETY DEPARTMENT THAT DURING THE TRANSPORTATION OF A BLADDERSCAN BVI 9400 DEVICE THE SHIPMENT BOX BEGAN SMOKING AND CAUGHT ON FIRE. THE PACKAGE WAS REMOVED AND EXTINGUISHED WITH A HAND HELD EXTINGUISHER. NO INJURIES WERE REPORTED, IN ADDITION IT WAS REPORTED THE DAMAGE WAS ISOLATED TO THIS ONE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 8006999 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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