Parker Flex-Tip H-PFNC-65Recalls & reported problems
Salter Labs · Endotracheal Tube, Preformed Nasal, High Volume Low Pressure, Cuffed (PFNC), Parker, 6.5mm · Class 2
All models of Parker Flex-Tip (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10749065031655), received between Oct 13, 2023 and Jan 24, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (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.
Reports received per month
Most reported problems
Device problems
- Gas/Air Leak1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 24, 2026Gas/Air Leak
IT WAS REPORTED THAT ON (B)(6) 2025, AFTER NASOTRACHEAL INTUBATION, A LEAK WAS IDENTIFIED THAT MAY HAVE CONTACTED THE NASAL BONE IMMEDIATELY POST-INTUBATION. THE NASAL TUBE WAS REMOVED AND REPLACED WITH A NEW TUBE. NO DELAY IN THERAPY, HARM, OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT. AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED 2 DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS REFER TO 3004748541-2026-00023 FOR THE SECOND REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24174883 ↗MalfunctionOct 13, 2023Leak/Splash; Leak/Splash
CUFFS ARE LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17935631 ↗
Other Tube, Tracheal (W/Wo Connector) devices
- Shiley 18875Covidien LP · Tube, tracheal (w/wo connector)4 deaths570 reports
- RUSCH IPN041476Teleflex Incorporated · Tube, tracheal (w/wo connector)10 recalls0 reports
- Shiley 18775Covidien LP · Tube, tracheal (w/wo connector)489 reports
- Shiley 18770Covidien LP · Tube, tracheal (w/wo connector)2 deaths434 reports
- Shiley 18880Covidien LP · Tube, tracheal (w/wo connector)2 deaths370 reports
- Shiley 18780Covidien LP · Tube, tracheal (w/wo connector)3 deaths286 reports
- Shiley 18770SCovidien LP · Tube, tracheal (w/wo connector)273 reports
- Shiley 18780SCovidien LP · Tube, tracheal (w/wo connector)251 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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