Parker Flex-TipRecalls & reported problems across all models
Salter Labs · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 42
- Deaths reported
- 1
- Injuries reported
- 8
- Recalls
- 0
We found 19 models of Parker Flex-Tip by Salter Labs in the FDA's device registry (GUDID). Together they are named in 42 adverse event reports in the FDA's MAUDE database, received between Jan 19, 2018 and Sep 18, 2026 — classified as 1 death, 8 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (16 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 Flex-Tip problems
Device problems
- Gas/Air Leak16
- Connection Problem3
- Material Integrity Problem3
- Separation Problem3
- Appropriate Device Problem Term/Code Not Available2
- Detachment of Device or Device Component2
- Difficult to Remove2
- Insufficient Device Problem Information2
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- Insufficient Information5
- Low Oxygen Saturation3
- Respiratory Insufficiency2
- Swelling/ Edema2
- Unspecified Tissue Injury2
- Cardiac Arrest1
- No Known Impact Or Consequence To Patient1
Parker Flex-Tip models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Parker Flex-Tip H-PFHV-70Tube, Tracheal (W/Wo Connector)1 death5 reports
- Parker Flex-Tip H-PFST-75Tube, Tracheal (W/Wo Connector)5 reports
- Parker Flex-Tip H-PFTVPU-80Tube, Tracheal (W/Wo Connector)4 reports
- Parker Flex-Tip H-PFTVVC-80Tube, Tracheal (W/Wo Connector)4 reports
- Parker Flex-Tip H-PFRC-80Tube, Tracheal (W/Wo Connector)3 reports
- Parker Flex-Tip H-PFTVVC-70Tube, Tracheal (W/Wo Connector)3 reports
- Parker Flex-Tip H-PFST-80Tube, Tracheal (W/Wo Connector)3 reports
- Parker Flex-Tip H-PFNC-65Tube, Tracheal (W/Wo Connector)2 reports
- Parker Flex-Tip H-PFNC-70Tube, Tracheal (W/Wo Connector)2 reports
- Parker Flex-Tip H-PFTVVC-75Tube, Tracheal (W/Wo Connector)2 reports
- Parker Flex-Tip H-PFHV-60Tube, Tracheal (W/Wo Connector)1 report
- Parker Flex-Tip H-PFHV-65Tube, Tracheal (W/Wo Connector)1 report
- Parker Flex-Tip H-PFHV-75Tube, Tracheal (W/Wo Connector)1 report
- Parker Flex-Tip H-PFHV-80Tube, Tracheal (W/Wo Connector)1 report
- Parker Flex-Tip H-PFTVPU-75Tube, Tracheal (W/Wo Connector)1 report
- Parker Flex-Tip H-PTCL-30Tube, Tracheal (W/Wo Connector)1 report
- Parker Flex-Tip H-PFST-65Tube, Tracheal (W/Wo Connector)1 report
- Parker Flex-Tip H-PSTDL-32Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)1 report
- Parker Flex-Tip H-PSTDL-35Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)1 report
Recent Parker Flex-Tip adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Patient-Device Incompatibility
Patient in EP "[electrophysiology]" for Watchman procedure on "[redacted]". Per documentation no complications during intubation or recovery. Anes induction at 1258, Anes end at 1359. Patient arrived to CCL "[cardiac cath lab]" recovery at 1400. Recovery was uneventful and patient was about to be discharged to home (in a wheelchair) when patient then complained of SOB "[shortness of breath]" and a lump in the throat and developed facial swelling. CXR showed: 1. Small right apical pneumothorax. 2. Pneumomediastinum and soft tissue gas throughout the lower neck and chest wall. 3. Patchy opacities throughout both lungs, most prominent at the right lung base, compatible with multifocal pneumonia. 4. Loop recorder overlies the left heart. Patient resp status continued to decline and decision was made to intubate patient. Patient transferred to ICU where bedside bronch was completed and a 1cm tracheal tear was found in the main carina. Patient was taken operating room for repair.
Patient problems: Pneumothorax; Stacking Breaths; Swelling/ Edema
MAUDE report 50818324 ↗MalfunctionSep 14, 2026Gas/Air Leak
It was reported that one week after intubation, the automatic cuff pressure monitor alarm sounded continuously. The tube was extubated, and the patient was immediately reintubated with a new tube. There was no reported delay in therapy, harm, or injury associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756313 ↗InjurySep 4, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50600214 ↗MalfunctionJun 26, 2026Infusion or Flow Problem
IT WAS REPORTED THAT, AFTER MEDICAL STAFF CONNECTED A CUFF PRESSURE GAUGE, THE PRESSURE DECREASED BY APPROXIMATELY 20 MMHG. THE TUBE WAS SUBSEQUENTLY EXTUBATED AND REPLACED WITH A NEW TUBE. THERE WAS NO REPORTED DELAY IN THERAPY, HARM, OR INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25637556 ↗MalfunctionApr 29, 2026Material Fragmentation
IT WAS REPORTED THAT DURING USE, THE INFLATION TUBE BROKE WITHOUT BECOMING DISLODGED. THE PATIENT WAS EXTUBATED, AND REINTUBATION WAS NOT PERFORMED. NO HARM OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Low Oxygen Saturation
MAUDE report 25038275 ↗MalfunctionMar 19, 2026Gas/Air Leak
IT WAS REPORTED THAT INTUBATION WAS PERFORMED ON (B)(6) 2026, AT 10:00 PM. ON (B)(6) 2026, THE ENDOTRACHEAL TUBE WAS EXCHANGED DUE TO DECREASED VENTILATION VOLUME. FOLLOWING EXTUBATION, THE MEDICAL STAFF INSPECTED THE DEVICE AND NOTED THAT THE CUFF WAS UNABLE TO BE INFLATED.
Patient problems: Low Oxygen Saturation
MAUDE report 24638800 ↗MalfunctionFeb 20, 2026Gas/Air Leak
IT WAS REPORTED, IMMEDIATELY AFTER INTUBATION NO INCREASE IN PERIPHERAL OXYGEN SATURATION (SPO2) WAS OBSERVED; THE TUBE WAS REMOVED AND REINTUBATION WAS PERFORMED WITH A NEW TUBE. THE CUFF REPORTEDLY HAD A LEAK; HOWEVER, THERE WAS NO REPORT OF A DELAY IN THERAPY, HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.
Patient problems: Insufficient Information
MAUDE report 24408163 ↗MalfunctionFeb 6, 2026Separation Problem
IT WAS REPORTED THAT IMMEDIATELY AFTER INTUBATION, THE INFLATION TUBE DETACHED, AND REINTUBATION WAS PERFORMED USING A NEW TUBE. THERE WAS NO REPORT OF HARM OR INJURY AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24283673 ↗MalfunctionJan 24, 2026Gas/Air Leak
IT WAS REPORTED THAT ON (B)(6) 2025, IMMEDIATELY FOLLOWING NASOTRACHEAL INTUBATION, A LEAK WAS IDENTIFIED. THE PATIENT WAS REINTUBATED USING ORAL INTUBATION. 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 SECOND OF TWO REPORTS REFER TO 3004748541-2026-00022 FOR THE FIRST REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24174890 ↗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 ↗MalfunctionJan 24, 2026Separation Problem
IT WAS REPORTED THAT ONE WEEK AFTER INTUBATION, THE INFLATION TUBE DETACHED, AND REINTUBATION WAS PERFORMED USING A NEW TUBE. NO HARM OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT. AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED 3 DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS REFER TO 3004748541-2026-00019 FOR THE FIRST REPORT. REFER TO 3004748541-2026-00020 FOR THE SECOND REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24174866 ↗MalfunctionJan 24, 2026Separation Problem
IT WAS REPORTED THAT SEVERAL DAYS AFTER INTUBATION, THE INFLATION TUBE DETACHED, AND REINTUBATION WAS PERFORMED USING A NEW TUBE. NO HARM OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT. AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED 3 DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS REFER TO 3004748541-2026-00019 FOR THE FIRST REPORT. REFER TO 3004748541-2026-00021 FOR THE THIRD REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24174865 ↗MalfunctionJan 24, 2026Deflation Problem
IT WAS REPORTED THAT SEVERAL HOURS AFTER INTUBATION, MEDICAL STAFF NOTICED THE CUFF WAS DEFLATED. THE PATIENT WAS REINTUBATED WITH A NEW TUBE. NO HARM OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT. AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED 3 DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS REFER TO 3004748541-2026-00020 FOR THE SECOND REPORT. REFER TO 3004748541-2026-00021 FOR THE THIRD REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24173625 ↗MalfunctionJan 23, 2026Gas/Air Leak
IT WAS REPORTED, IMMEDIATELY AFTER INTUBATION AN AIR LEAK OCCURRED. THE TUBE WAS REMOVED AND REINTUBATION WITH A NEW TUBE WAS PERFORMED. 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 24169057 ↗InjuryJan 16, 2026Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3004748541-2025-00162 FOR THE FIRST REPORT. THE STAFF REPORTED, THE PRODUCT WAS MORE DIFFICULT AND TRAUMATIC TO POSITION. NO ADDITIONAL INFORMATION PROVIDED CONCERNING THE REPORTED INCIDENT.
Patient problems: Unspecified Tissue Injury
MAUDE report 24097900 ↗
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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