FLOVAC 60-6005-505Recalls & reported problems
Conmed Corporation · FLOVAC HANDCONTROLLED SUCTION/IRRIGATION · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30653405034753), received between Feb 10, 2017 and Apr 6, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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
- Delivered as Unsterile Product1
- Packaging Problem1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Patient Involvement2
- Not Applicable1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2018Delivered as Unsterile Product; Delivered as Unsterile Product
THE DISTRIBUTOR IN (B)(4) REJECTED ONE 60-6005-505, FLOVAC LAP S/I W/5MM CANNULA, DUE TO DAMAGED PACKAGING. IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION PRIOR TO DISTRIBUTION TO AN END-USER. THIS REPORT IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH REOCCURRENCE.
Patient problems: No Patient Involvement
MAUDE report 7403782 ↗MalfunctionFeb 26, 2018Packaging Problem; Packaging Problem
THE DISTRIBUTOR IN (B)(6) REPORTED "DAMAGE" ON THE STERILE POUCH OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT AS THIS DEFECT WAS DISCOVERED DURING INCOMING INSPECTION. THIS REPORT IS RAISED ON THE BASIS OF A STERILITY BREACH FOUND DURING THE DEVICE EVALUATION.
Patient problems: No Patient Involvement
MAUDE report 7296190 ↗MalfunctionFeb 10, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE END-USER REPORTED THAT DURING PRE-OP TESTING, A TEAR IN THE PACKAGE OF A FLOVAC SUCTION AND IRRIGATION HANDPIECE WAS FOUND. IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT WITH THIS REPORTED DEVICE, AS THE PACKAGING DAMAGE WAS DISCOVERED DURING CLINICAL INSPECTION WITH PRE-OP SETUP.
Patient problems: Not Applicable
MAUDE report 6322558 ↗
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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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