Parker H-PFST-75Recalls & reported problems
Salter Labs · Parker Flex-Tip Tracheal Tube with Stylet, High Volume Low Pressure, Cuffed (PFST), 7.5mm Parker Original DID: 10749065801753 . · Class 2
All models of Parker (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607411959288), received between Jul 10, 2018 and Aug 29, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K984528); they may or may not involve this specific model.
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
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Hypoxia1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2024Gas/Air Leak; Gas/Air Leak
DURING INTUBATION, A LEAK WAS FOUND. SCRATCHES FOUND ON THE CUFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20103279 ↗MalfunctionAug 29, 2024Gas/Air Leak; Gas/Air Leak
AFTER INTUBATION, A LEAK WAS FOUND AFTER 2 DAYS AND THERE WAS A WOUND FOUND ON THE CUFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20103089 ↗MalfunctionJul 10, 2018Material Integrity Problem; Material Integrity Problem
PATIENT UNDERWENT SURGERY AND SUBSEQUENTLY DEVELOPED RESPIRATORY INSUFFICIENCY. CT SCAN REVEALED PNEUMOMEDIASTINUM. PATIENT WAS TRANSFERRED FOR FURTHER EVALUATION. NO OTHER INJURY IDENTIFIED.
Patient problems: Hypoxia
MAUDE report 7674235 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K984528. One submission often covers many models, so check the product and lot details in each record.
- Z-1399-2017 · Dec 16, 2016 · TerminatedParker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-
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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