Parker Flex-Tip H-PFHV-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10749065011701), received between Feb 29, 2024 and Jan 16, 2026 — classified as 1 death, 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (3 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, 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 FIRST OF TWO REPORTS. REFER TO 3004748541-2026-00014 FOR THE SECOND 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 24097899 ↗
• MalfunctionOct 31, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THE PATIENT, WHO WAS BROUGHT TO THE EMERGENCY ROOM (ER) ON (B)(6) 2025 DUE TO A LOW LEVEL OF CONSCIOUSNESS, WAS INTUBATED AT THAT TIME. ON (B)(6) 2025, THE INFLATING TUBE (WHICH WAS CONNECTED TO AN AUTOMATIC CUFF PRESSURE GAUGE) DETACHED WHILE TWO NURSES LOWERED THE BED AND ATTEMPTED TO HOLD THE CIRCUIT TOGETHER. THE PATIENT WAS REINTUBATED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437862 ↗
• MalfunctionSep 2, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED: AFTER THE OPERATION WAS COMPLETED, THE MEDICAL STAFF NOTICED THAT AIR LEAK HAD OCCURRED, THE PATIENT WAS NOT REINTUBATED. THERE WAS NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22945090 ↗
• DeathAug 1, 2025Connection Problem; Gas/Air Leak; Connection Problem; Gas/Air Leak

  IT WAS REPORTED A LEAK OCCURRED FROM THE CUFF DURING INTUBATION OF THE PATIENT WITH HEART FAILURE. THE DOCTOR PERFORMED BASIC LIFE SUPPORT AND INTUBATED THE TUBE AFTER THE PATIENT HAD GONE INTO CARDIOPULMONARY ARREST. ONCE AN ALARM SOUNDED THAT THE CIRCUIT HAD BEEN DISCONNECTED, BUT THE ALARM STOPPED WHEN AIR WAS INJECTED INTO THE CUFF. AFTER THE PATIENT DIED, A COMPUTED TOMOGRAPHY SCAN (CT) SCAN OF THE INTUBATION REVEALED NO ABNORMALITIES; UPON RETURNING TO THE INTENSIVE CARE UNIT (ICU), IT WAS CONFIRMED THAT AIR WAS LEAKING FROM THE CUFF OF THE ENDOTRACHEAL TUBE. IT WAS ADDITIONALLY REPORTED, THE HOSPITAL BELIEVED THE PATIENT DIED BECAUSE SHE WAS NOT WELL TO BEGIN WITH.

  Patient problems: Cardiac Arrest

  MAUDE report 22692865 ↗
• MalfunctionFeb 29, 2024Mechanical Problem; Gas/Air Leak; Mechanical Problem; Gas/Air Leak

  A CUFF LEAK WAS DISCOVERED. THE PATIENT WAS EXTUBATED AND RE-INTUBATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18813427 ↗