InHealth Technologies; Blom-Singer; Dual Valve DV 2010-NSRecalls & reported problems
Freudenberg Medical, LLC · Class 1
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 00813307010951), received between Mar 16, 2026 and Mar 16, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Separation Problem” (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
- Separation Problem1
Patient problems
- Aspiration/Inhalation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 16, 2026Separation Problem
THE SPEAKING VALVE WAS INSERTED 5 DAYS PRIOR TO THE INCIDENT. THE PATIENT ATTENDED ED WITH UNCONTROLLED ASPIRATION OF SECRETIONS AND FOOD/FLUIDS FROM VALVE. ON CLOSER INSPECTION OF THE VALVE, THERE APPEARED TO BE NO ANTERIOR FLAP. TRACHEOSCOPY IDENTIFIED A SMALL PLASTIC FLAP IN THE CARINA BUT WAS NOT SEEN ON XRAY. THE PATIENT REPORTED THAT HE HAD BEEN CLEANING HIS VALVE IN THE NORMAL WAY, WITH NO FORCE AND WITH THE CORRECT EQUIPMENT. SLT THAT PLACED THE VALVE SAID THAT SHE HAD NOT NOTICED ANY PROBLEMS WITH THE VALVE AT THE TIME OF INSERTION.
Patient problems: Aspiration/Inhalation
MAUDE report 24604342 ↗
Other Brush, Cleaning, Tracheal Tube devices
- Centurion 6225STCenturion Medical Products Corporation · BRUSH, CLEANING, TRACHEAL TUBE1 recall0 reports
- InHealth Technologies; Blom-Singer; Classic IN 1608-NSFreudenberg Medical, LLC · Brush, Cleaning, Tracheal Tube1 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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