Rovers® Cervex-Brush® 491461Recalls & reported problems
Rovers Medical Devices B.V. · Cervical cell sampler · 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 08719189246483), received between Oct 27, 2023 and Oct 27, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
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.
MalfunctionOct 27, 2023Break; Break
IT WAS REPORTED THAT WHILE USING BD ROVERS® CERVIX-BRUSH® THAT THERE WAS A SWAB BREAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WAS THERE ANY PATIENT IMPACT?- "NO LONG TERM HARM- ONLY FROM NEEDING TO BE REMOVED S/P BEING DISLODGED" CUSTOMER REPORTS THAT CYTOBRUSH DISLODGED FROM STEM FOR CAT 491461 LOT 41099.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18026025 ↗
Other Spatula, Cervical, Cytological devices
- Rovers® Cervex-Brush® Combi 491462Rovers Medical Devices B.V. · Spatula, Cervical, Cytological1 report
- digene® HC2 DNA Collection Device 1Qiagen Sciences Inc. · Spatula, Cervical, Cytological1 report
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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