Parker H-PFHV-75Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00607411952746), received between Sep 21, 2023 and Jul 22, 2026 — classified as 1 death, 18 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 (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 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionNov 7, 2025Disconnection; Connection Problem; Disconnection; Connection Problem

  IT WAS REPORTED THAT INFLATING TUBE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501760 ↗
• MalfunctionSep 26, 2025Connection Problem; Connection Problem

  IT WAS REPORTED, WHEN THE ALARM FOR DECREASED MINUTE VENTILATION SOUNDED, THE MEDICAL STAFF FOUND THE INFLATING TUBE HAD DISCONNECTED FROM THE TUBE; MANUAL VENTILATION WAS PERFORMED USING A BAG VALVE MASK (BVM), AND THE TUBE WAS REINSERTED. IT WAS ADDITIONALLY REPORTED, THE PATIENT PASSED AWAY; HOWEVER, THE MEDICAL STAFF NOTED, THE PATIENT'S DEATH WAS UNRELATED TO THE TUBE ISSUE, AS THE PATIENT HAD ORIGINALLY SUFFERED A CEREBRAL CONTUSION. NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THE EVENT THAT LEAD TO THE CEREBRAL CONTUSION.

  Patient problems: Insufficient Information

  MAUDE report 23159041 ↗
• MalfunctionJul 11, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE PATIENT WAS INITIALLY INTUBATED WITH THE USE OF PARKER FLEX-TIP PFHV TRACHEAL TUBE, CUFFED (REF H-PFHV-75, LOT 2412HV3716L BUT WAS UNSUCCESSFUL. THE TUBE IS STIFF AND CAN POTENTIALLY INJURE PATIENT'S ANTERIOR TRACHEA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22487278 ↗
• MalfunctionJul 3, 2025Disconnection; Connection Problem; Disconnection; Connection Problem

  IT WAS REPORTED THAT FROM (B)(6) 2025 THE ITEM WAS IN USE; ON (B)(6), THE SEDATIVE DOSE WAS REDUCED FROM 7:30 A.M. FOR A SCHEDULED EXTUBATION. AT 8:30 A CUFF LEAK WAS CONFIRMED, AND AIR WAS DELIVERED, BUT NO PRESSURIZATION WAS ACHIEVED; WHEN CHECKED, THE INFLATING TUBE WAS DISCONNECTED. THE TRACHEAL TUBE AND INFLATING TUBE WERE FIXED TOGETHER. THE TUBE WAS EXTUBATED BY DOCTOR; THE PATIENT WAS NOT REINTUBATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401214 ↗
• MalfunctionJun 20, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED, AFTER INTUBATION IN THE EMERGENCY ROOM (ER), THE PATIENT WAS TRANSFERRED TO THE WARD. IMMEDIATELY AFTER PLACING THE PATIENT ON THE VENTILATOR IN THE WARD, A LOW PRESSURE ALARM ON THE VENTILATOR WENT OFF AND A CUFF LEAK OCCURRED (WITHIN THE FIRST HOUR OF USE). ADDITIONAL AIR WAS INJECTED, BUT THE LEAK WAS NOT RESOLVED; THE PATIENT WAS RE-INTUBATION. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22302955 ↗
• MalfunctionJun 11, 2025Failure to Deflate; Failure to Deflate

  THE REPORT OF THE CUFF TO THE ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 7.5MM THAT DID NOT INITIALLY DEFLATE WHEN REMOVING AIR FROM THE CUFF IS A REPORTABLE INCIDENT. ALTHOUGH NO PATIENT HARM, INJURY WAS REPORTED, THE INABILITY TO DEFLATE THE CUFF COULD HAVE DELAYED EXTUBATION, POTENTIALLY RESULTING IN SERIOUS INJURY SUCH AS AIRWAY TRAUMA OR HYPOXIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22188822 ↗
• MalfunctionJun 10, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED, AFTER INTUBATION IN THE EMERGENCY ROOM (ER), THE PATIENT WAS TRANSFERRED TO THE WARD. IMMEDIATELY AFTER PLACING THE PATIENT ON THE VENTILATOR IN THE WARD, A LOW PRESSURE ALARM ON THE VENTILATOR WENT OFF AND A CUFF LEAK OCCURRED (WITHIN THE FIRST HOUR OF USE). ADDITIONAL AIR WAS INJECTED, BUT THE LEAK WAS NOT RESOLVED. THE PATIENT WAS RE-INTUBATED; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177066 ↗
• MalfunctionJun 3, 2025Gas/Air Leak; Gas/Air Leak

  PRIOR TO INTUBATION, A PRELIMINARY LEAK CHECK WAS PERFORMED, AND NO PROBLEMS WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137578 ↗
• MalfunctionFeb 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE CUFF RUPTURED SHORTLY AFTER INTUBATION AS THIS INCIDENT OCCURRED TWICE WITH THE SAME PRODUCT 2 MDRS WILL BE SUBMITTED DOCUEMTINT THE INCIDENTS. THE SECOND REPORT # IS 3000219639-2025-00018.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381389 ↗
• DeathDec 5, 2024Inflation Problem; Inflation Problem

  IT WAS STATED BY CUSTOMER THAT "WHILE INTUBATING THE PATIENT, THE INFLATING TUBE WAS DISLODGED AND THE CUFF ATROPHIED. THE PATIENT LATER DIED. THE HOSPITAL WAS OF THE OPINION THAT THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE DISLODGED INFLATING TUBE AND THE DEATH. WE DO NOT KNOW THE CAUSE-AND-EFFECT RELATIONSHIP".

  Patient problems: Decreased Respiratory Rate; Unintended Extubation

  MAUDE report 20858113 ↗
• MalfunctionNov 27, 2024Inflation Problem; Inflation Problem

  THE INFLATING TUBE HAD FALLEN OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20790924 ↗
• MalfunctionAug 29, 2024Gas/Air Leak; Gas/Air Leak

  LEAK AT THE BASE OF THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20103138 ↗
• MalfunctionJun 26, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED, APPROXIMATELY 10 MINUTES AFTER PATIENT INTUBATION, THE ANESTHESIOLOGIST'S ALARM WENT OFF. THE ENDOTRACHEAL TUBE (ETT) WAS REPLACED WITH A NEW ONE; AND AN UNSPECIFIED "NON-SERIOUS INJURY" WAS NOTED. IT WAS ADDITIONALLY REPORTED, A LEAK FROM THE BASE OF THE PILOT BALLOON WAS VERIFIED, NO OTHER PROBLEMS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19620298 ↗
• MalfunctionJun 12, 2024Device Slipped; Unintended Movement; Device Slipped; Unintended Movement

  THE INFLATING TUBE EASILY SLIPPED WHEN MOVED TO ADJUST THE POSITION OF THE TRACHEAL TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19518976 ↗
• MalfunctionSep 21, 2023Connection Problem; Connection Problem

  ENDOTRACHEAL TUBE IS UNABLE TO HOLD CONNECTOR WHICH REQUIRE TO CONNECT TO CIRCUIT OF VENTILATOR TO PROVIDE VENTILATION.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 17794271 ↗

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 · 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-