GIBECK IPN929912Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 14026704929846), received between Apr 20, 2026 and Jul 28, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Fitting Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50058854 ↗
• MalfunctionJul 28, 2026Fitting Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50058810 ↗
• MalfunctionApr 20, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT "THE USER WAS UNABLE TO CONNECT THE OXYGEN PORT OF THE TRACH-VENT TO THE TRACHEOSTOMY TUBE DURING USE, AS THE CONNECTION WAS TOO LOOSE. IT OCCURRED TO (B)(4) UNITS IN A ROW, TO THE SAME PATIENT. THEREFORE, A NEW UNIT OF THE DIFFERENT LOT# (LOT#: UNKNOWN) WAS USED TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT OCCURRED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931179 ↗
• MalfunctionApr 20, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT "THE USER WAS UNABLE TO CONNECT THE OXYGEN PORT OF THE TRACH-VENT TO THE TRACHEOSTOMY TUBE DURING USE, AS THE CONNECTION WAS TOO LOOSE. IT OCCURRED TO 2 UNITS IN A ROW, TO THE SAME PATIENT. THEREFORE, A NEW UNIT OF THE DIFFERENT LOT# (LOT#: UNKNOWN) WAS USED TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT OCCURRED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931141 ↗