InHealth Technologies; Blom-Singer; Classic IN 1606-NSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813307011071), received between Sep 8, 2025 and Sep 8, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Insert” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2025Difficult to Insert; Migration; Difficult to Insert; Migration

  INCIDENT DESCRIPTION: " A 67-YEAR-OLD PATIENT WITH A TRACHEOSTOMY AND A VOICE PROSTHESIS FOLLOWING A TOTAL LARYNGECTOMY FOR RECURRENT INVASIVE SQUAMOUS CELL CARCINOMA OF THE RIGHT GLOTTIC CAVITY EXPERIENCED A COMPLICATION DURING IMPLANT REPLACEMENT ON (B)(6). THE REPLACEMENT ATTEMPT FAILED, AND DURING THE PROCEDURE, THE VOICE IMPLANT FLANGE WAS ASPIRATED. A SHILEY 8 TRACHEOSTOMY TUBE WITH AN INFLATED CUFF WAS INSERTED SUBSEQUENTLY." PATIENT IMPACT: " THE PATIENT EXPERIENCED CHOKING DURING THE INCIDENT. THERE WAS NO BUZZER IN THE CUBICLE, AND THE SURGEON HAD TO CALL FOR HELP VOCALLY. THE FLANGE WAS NOT VISUALIZED IN THE ESOPHAGUS DURING ENDOSCOPY. AN ATTEMPT TO INSERT A LONGER 8 MM IMPLANT FAILED, AS THE FLANGE COULD NOT BE DEPLOYED. THE PATIENT UNDERWENT REPLACEMENT SURGERY UNDER GENERAL ANESTHESIA WITH A 10 MM BLOM-SINGER IMPLANT ON (B)(6) AND WAS DISCHARGED WITHOUT FURTHER COMPLICATIONS ON (B)(6). NO RETAINED EVIDENCE WAS KEPT BY THE FACILITY."

  Patient problems: Airway Obstruction; Aspiration/Inhalation; Choking; Foreign Body In Patient

  MAUDE report 22991909 ↗