Parker H-PSTDL-37Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00607411959493), received between Mar 29, 2024 and Dec 19, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K092886); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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, 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 ↗
• MalfunctionNov 5, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING INTUBATION, THERE WAS RESISTANCE. UPON EXAMINATION WITH A VIDEO LARYNGOSCOPE, BLEEDING WAS OBSERVED. IT APPEARED DIFFICULT TO PASS THE ENDOSCOPE THROUGH THE POSTERIOR PHARYNGEAL WALL, WHICH RESULTED IN MUCOSAL DAMAGE THE TUBE WAS REMOVED, AND ORAL INTUBATION WAS PERFORMED. THIS INCIDENT CAUSED A DELAY IN INTUBATION, PATIENT THERAPY, AND HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480010 ↗
• MalfunctionMay 16, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED, DURING LAPAROSCOPIC RESECTION OF A MALIGNANT LUNG TUMOR, A TRACHEAL TUBE WAS INSERTED INTO THE PATIENT IN THE SUPINE POSITION. AFTER THE PATIENT'S POSITION WAS CHANGED TO THE LEFT SIDE LYING POSITION THE PATIENT WAS CHECKED WITH A BRONCHIAL FIBERGLASS AND A LEAK FROM THE BRONCHIAL CUFF WAS DISCOVERED. THE PATIENT WAS RETURNED TO THE SUPINE POSITION AND REINTUBATED. THE CUFF WAS [SUBSEQUENTLY] INSPECTED AND A CUT WAS VERIFIED; THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038654 ↗
• MalfunctionSep 24, 2024Gas/Air Leak; Gas/Air Leak

  FOUND A LEAK FROM THE BASE OF THE PILOT BALLOON. WENTY MINUTES AFTER INTUBATING THE PATIENT, THE CUFF WAS LEAKING, SO THE TUBE WAS REMOVED AND A DIFFERENT TUBE WAS REINTUBATED.WHEN THE ACTUAL PRODUCT WAS RETURNED TO OUR COMPANY FOR VERIFICATION, THE BRONCHIAL CUFF WAS FINE, BUT THE TRACHEAL CUFF WAS ATROPHIED. NEXT, WE VERIFIED WITH COLORED WATER AND FOUND A LEAK FROM THE BASE OF THE PILOT BALLOON.WE CONSIDER THIS AREA TO BE A MANUFACTURING DEFECT.YOUR COMPANY, I BELIEVE, PERFORMS A 12-HOUR LEAK CHECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292680 ↗
• MalfunctionAug 6, 2024Leak/Splash; Leak/Splash

  WAS A LEAK FROM THE BASE OF THE PILOT BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19920117 ↗
• MalfunctionJul 12, 2024Leak/Splash; Gas/Air Leak; Leak/Splash; Gas/Air Leak

  FOUND LEAK AT ROOT OF BRONCHIAL CUFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19731739 ↗
• MalfunctionMar 29, 2024Mechanical Problem; Mechanical Problem

  MULTIPLE SCRATCHES WERE FOUND ON THE TRACHEAL CUFF.  AFTER CHECKING CUFF PRESSURE, TUBE WAS INTUBATED INTO THE PATIENT, AND THE PATIENT WAS IMMEDIATELY EXTUBATED BECAUSE HE WAS UNABLE TO VENTILATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19008105 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092886. One submission often covers many models, so check the product and lot details in each record.

• Z-1399-2017 · Dec 16, 2016 · Terminated
  Parker 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-