InHealth Technologies; Blom-Singer BE 2014Recalls & reported problems
Freudenberg Medical, LLC · 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 00813307010098), received between Aug 24, 2017 and Aug 24, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Leak/Splash” (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.
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- Pneumonia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 24, 2017Leak/Splash; Leak/Splash
PATIENT POSTED ON AN INTERNET BLOG ON (B)(6) 2016; THEY HAD A VOICE PROSTHESIS THAT HAD A "FLAP" THAT "CURLED" CAUSING FLUIDS TO BE ASPIRATED. THE FLUID ASPIRATING THEN LEAD TO PNEUMONIA. FOLLOW UP WAS CONDUCTED WITH THE PATIENT AND IT WAS CONFIRMED THEY RECEIVED TREATMENT FOR PNEUMONIA FOLLOWING FLUID ASPIRATION.
Patient problems: Pneumonia
MAUDE report 6817253 ↗
Other Prosthesis, Laryngeal (Taub) devices
- InHealth Technologies; Blom-Singer; Classic IN 1610-LFFreudenberg Medical, LLC · Prosthesis, Laryngeal (Taub)1 recall0 reports
- InHealth Technologies; Blom-Singer; Classic IN 1610-LEFFreudenberg Medical, LLC · Prosthesis, Laryngeal (Taub)1 recall0 reports
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- Provox ActiValve Strong 6 mm 7161Atos Medical AB · Prosthesis, Laryngeal (Taub)3 reports
- Provox Vega 22.5Fr 6mm 8283Atos Medical AB · Prosthesis, Laryngeal (Taub)2 reports
- Provox Vega 17Fr 6mm 8271Atos Medical AB · Prosthesis, Laryngeal (Taub)2 reports
- Provox ActiValve Strong 4.5 mm 7160Atos Medical AB · Prosthesis, Laryngeal (Taub)2 reports
- Provox Vega 22.5Fr 10mm 8285Atos Medical AB · Prosthesis, Laryngeal (Taub)2 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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