Parker H-PFNC-70Recalls & reported problems
Salter Labs · Endotracheal Tube, Preformed Nasal, High Volume Low Pressure, Cuffed (PFNC), Parker, 7.0mm Parker Original DID: 10749065031709. · Class 2
All models of Parker (13)
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 00607411954436), received between Oct 8, 2025 and Apr 12, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Gas/Air Leak2
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.
MalfunctionApr 12, 2026Gas/Air Leak
IT WAS REPORTED: PATIENT HAD BEEN NASALLY INTUBATED WITH THIS NASAL ETT, WITHIN 10 MINUTES MEDICAL STAFF NOTICED A CUFF LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24853056 ↗MalfunctionOct 8, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED: AFTER INTUBATION, THE MEDICAL STAFF TRIED TO INFLATE THE CUFF, BUT THEY COULD NOT, THE TUBE WAS CHANGED. AFTER THE TUBE CHANGED THEY ATTEMPTED TO INFLATE THE CUFF AND IT WOULD NOT INFLATE. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23251538 ↗
Other Tube, Tracheal (W/Wo Connector) devices
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- 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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