ParkerRecalls & reported problems across all models
Salter Labs · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 71
- Deaths reported
- 2
- Injuries reported
- 1
- Recalls
- 0
We found 13 models of Parker by Salter Labs in the FDA's device registry (GUDID). Together they are named in 71 adverse event reports in the FDA's MAUDE database, received between Jul 10, 2018 and Sep 3, 2026 — classified as 2 deaths, 1 injury, 68 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (29 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Parker problems
Device problems
- Gas/Air Leak29
- Material Integrity Problem8
- Connection Problem6
- Disconnection6
- Deflation Problem4
- Inflation Problem4
- Mechanical Problem4
- Infusion or Flow Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions58
- Insufficient Information4
- Skin Inflammation/ Irritation3
- Decreased Respiratory Rate2
- Death1
- Hypoxia1
- No Known Impact Or Consequence To Patient1
- Unintended Extubation1
Parker models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Parker H-PFHV-75Tube, Tracheal (W/Wo Connector)1 death19 reports
- Parker H-PFHV-80Tube, Tracheal (W/Wo Connector)12 reports
- Parker H-PFHV-70Tube, Tracheal (W/Wo Connector)11 reports
- Parker H-PSTDL-37Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)10 reports
- Parker H-PFST-70Tube, Tracheal (W/Wo Connector)1 death5 reports
- Parker H-PFNC-65Tube, Tracheal (W/Wo Connector)3 reports
- Parker H-PFST-75Tube, Tracheal (W/Wo Connector)3 reports
- Parker H-PFNC-70Tube, Tracheal (W/Wo Connector)2 reports
- Parker H-PSTDL-35Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)2 reports
- Parker H-PFHV-85Tube, Tracheal (W/Wo Connector)1 report
- Parker H-PTCL-35Tube, Tracheal (W/Wo Connector)1 report
- Parker H-PFST-80Tube, Tracheal (W/Wo Connector)1 report
- Parker H-PSTDL-32Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)1 report
Recent Parker adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2026Disconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50599665 ↗MalfunctionJul 30, 2026Gas/Air Leak
It was reported that the inflation port of the endotracheal tube (ETT) did not seem to be holding pressure, and they elected to extubate the patient. Multiple attempts were made to reintubate the patient using orogastric tube (OGT)/nasogastric tube (NGT) without success; the patient reportedly had a lot of secretions and blood in the oropharynx. Once the patient was successfully reintubated the ventilator alarm stopped and the carbon dioxide (CO2) trace was fine. No additional information, concerning patient outcome, was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50078240 ↗MalfunctionJul 22, 2026Disconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25905926 ↗MalfunctionApr 23, 2026Disconnection
IT WAS REPORTED THAT DURING SURGERY, THE INFLATION TUBE BECAME DISLODGED FROM THE TUBE; HOWEVER, REINTUBATION WAS NOT PERFORMED. NO HARM OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965354 ↗MalfunctionApr 13, 2026Gas/Air Leak
IT WAS REPORTED THAT IMMEDIATELY AFTER INTUBATION, AN AIR LEAK WAS NOTED. THE TUBE WAS EXTUBATED AND A NEW TUBE WAS PLACED. NO HARM OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24867240 ↗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 ↗MalfunctionFeb 23, 2026Disconnection
IT WAS REPORTED THAT A PATIENT WITH AN INFECTIOUS DISEASE WAS INTUBATED ON (B)(6) 2025. ON (B)(6) 2025, DURING EPISODES OF HEAVY COUGHING, THE SLIP JOINT ON THE TRACHEAL TUBE BECAME LOOSE. THE SLIP JOINT WAS RECONNECTED, BUT IT DETACHED AGAIN. THE PATIENT WAS SUBSEQUENTLY REINTUBATED USING A TUBE FROM A DIFFERENT MANUFACTURER; HOWEVER, THE SLIP JOINT ON THAT DEVICE ALSO BECAME LOOSE. THERE WERE NO REPORTS OF THERAPY DELAY, HARM, OR INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24423218 ↗MalfunctionFeb 6, 2026Infusion or Flow Problem
IT WAS REPORTED THAT ON (B)(6) 2026, DURING ORAL CARE FOR THE PATIENT, THE PILOT BALLOON WAS FOUND UNDER THE BED. THE INFLATION TUBE WAS PINCHED WITH FORCEPS AS AN EMERGENCY MEASURE, AND THE PATIENT WAS SUBSEQUENTLY REINTUBATED WITH A NEW TUBE. ALTHOUGH THERE WAS A TEMPORARY DROP IN SPO2, THE PATIENT IS CURRENTLY ON MECHANICAL VENTILATION WITHOUT ISSUE. THERE WAS NO REPORT OF HARM OR INJURY AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24276773 ↗MalfunctionJan 23, 2026Gas/Air Leak
IT WAS REPORTED:THAT DURING INTUBATION, THE INFLATING TUBE DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24172859 ↗MalfunctionJan 8, 2026Infusion or Flow Problem
IT WAS REPORTED THAT TWO DAYS AFTER INITIATING USE, AN AIR LEAKAGE ALARM OCCURRED. THE TUBE WAS EXTUBATED AND REPLACED WITH A NEW TUBE. THERE WAS NO REPORT OF A DELAY IN THERAPY, HARM, OR INJURY AS A RESULT OF THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24011639 ↗MalfunctionDec 19, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT IMMEDIATELY AFTER INTUBATION AN AIR LEAK OCCURRED. THE TUBE WAS REMOVED, AND THE PATIENT WAS REINTUBATED WITH A NEW TUBE. THERE WERE NO REPORTS OF THERAPY DELAYS, HARM, OR INJURY RESULTING FROM THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23857714 ↗InjuryDec 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT AFTER THE OPERATION, MEDICAL STAFF OBSERVED A LACERATION IN THE MEMBRANOUS PORTION OF THE LEFT MAIN BRONCHUS, LOCATED AT THE POSITION OF THE BLUE CUFF. A THORACOTOMY WAS PERFORMED, AND THE DAMAGED AREA WAS SUTURED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE PATIENT'S OUTCOME.
Patient problems: Insufficient Information
MAUDE report 23857698 ↗MalfunctionDec 19, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT AFTER INTUBATION, THE BLUE CUFF DEFLATED AND COULD NOT BE REINFLATED. REINTUBATION WAS PERFORMED USING A NEW TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23857640 ↗MalfunctionDec 19, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT AFTER INTUBATION, A CUFF LEAK OCCURRED. THE PATIENT WAS REINTUBATED WITH A NEW TUBE USING A BOUGIE, BUT ANOTHER CUFF LEAK OCCURRED IMMEDIATELY, REQUIRING A SECOND REINTUBATION. THERE WERE NO REPORTS OF THERAPY DELAY, HARM, OR INJURY RESULTING FROM THIS EVENT. AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS REFER TO (B)(4) FOR THE FIRST REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23857462 ↗MalfunctionDec 19, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT AFTER INTUBATION, A CUFF LEAK OCCURRED. THE PATIENT WAS REINTUBATED WITH A NEW TUBE USING A BOUGIE, BUT ANOTHER CUFF LEAK OCCURRED IMMEDIATELY, REQUIRING A SECOND REINTUBATION. THERE WERE NO REPORTS OF THERAPY DELAY, HARM, OR INJURY RESULTING FROM THIS EVENT. SUNMED HOLDINGS LLC RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS REFER TO 3004748541-2025-00156 FOR THE SECOND REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23857420 ↗
Other Salter Labs products
All Salter Labs devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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