Parker H-PFHV-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00607411952739), received between Mar 14, 2024 and Feb 6, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• MalfunctionNov 5, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT AIR COULD NOT ENTER THE CUFF. THE TUBE WAS REMOVED, AND THE PATIENT WAS REINTUBATED WITH A NEW TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477417 ↗
• MalfunctionMay 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  WHEN THE PATIENT WAS MOVING TO BED AFTER REHABILITATION, THE INFLATING TUBE WAS DISLODGED. THE HOSPITAL SAID THAT THE INFLATING TUBE WAS NOT POSITIONED IN THE SLIT PORTION OF THE STREAM GUARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023868 ↗
• MalfunctionDec 10, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE VERY WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20897768 ↗
• MalfunctionNov 27, 2024Inflation Problem; Inflation Problem

  THE TRACHEAL TUBE COULD NO LONGER BE REMOVED. THE CUFF WAS DEFLATED, AND WHEN IT WAS PULLED OUT TO ABOUT 14 CM, THERE WAS RESISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20790878 ↗
• MalfunctionNov 8, 2024Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  TWO SMALL SCRATCHES ON THE CUFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20643140 ↗
• MalfunctionOct 31, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT "WHEN WE TRIED TO REMOVE THE CUFF OF AN INTUBATED TRACHEAL TUBE AFTER DEGASSING IT, THE CUFF GOT CAUGHT IN THE AIRWAY AROUND 18 CM AND WAS DIFFICULT TO REMOVE SEVERAL TIMES".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582330 ↗
• MalfunctionJun 18, 2024Deflation Problem; Connection Problem; Deflation Problem; Connection Problem

  CONFIRMED INFLATING TUBE WAS DISCONNECTED. DESCRIPTION OF COMPLAINT INTUBATED FOR SURGERY ON MAY 4 AND ADMITTED DIRECTLY TO HCU.THE TRACHEAL TUBE WAS FIXED WITH A BITE BLOCK AND FIXTURE, AND AN AUTOMATIC CUFF PRESSURE GAUGE WAS ALSO ATTACHED.ON MAY 13, A CUFF PRESSURE ALARM WENT OFF IN THE HCU, AND THE STAFF RESPONDED TO THE ALARM , AFTER WHICH STAFF OBSERVED A PILOT BALLOON FALLING ONTO THE BED. WE CONFIRMED THAT THE INFLATING TUBE HAD BEEN DISCONNECTED. THE AREA WHERE UV GLUE WAS APPLIED WAS WITHIN 1 CM OF THE TIP.COULD THIS BE DUE TO INADEQUATE ADHESION BECAUSE THE INFRATING TUBE WAS BARELY INSERTED DURING MANUFACTURING?WHAT IS YOUR COMPANY'S OPINION?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563719 ↗
• MalfunctionMar 29, 2024Leak/Splash; Mechanical Problem; Leak/Splash; Mechanical Problem

  CRACKED CUFF VALVE. "THIS INCIDENT OCCURRED LAST WEEKEND. IT WAS REPORTED TO ME THAT THE ENDOTRACHEAL TUBE CUFF WAS NOT HOLDING PRESSURE. THE PATIENT WAS SUBSEQUENTLY RE- INTUBATED WITH A DIFFERENT TUBE (SAME SIZE AND LOT#) AND THE SECOND CUFF WAS AGAIN, NOT HOLDING PRESSURE. AFTER EXAMINING THE VALVE ON BOTH TUBES IT WAS NOTED THAT EITHER THE VALVE OR PILOT BALLOON WERE CRACKED. THE ANESTHETIST INFLATED THE BALLOON AND OCCLUDED THE PILOT LINE TO KEEP THE CUFF INFLATED. THIS WAS A VERY UNUSUAL OCCURRENCE. I WAS NOT PRESENT, BUT ASSUME IT WAS RATHER A MANUFACTURING DEFECT THAN DAMAGE FROM HANDLING." HAS OCCURRED MULTIPLE TIMES AND TWICE ON ONE PATIENT. TUBES TESTED FINE BUT FAILED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19007057 ↗
• MalfunctionMar 14, 2024Material Twisted/Bent; Material Twisted/Bent

  TRACHEAL TUBE WAS KINKED AND THE SUCTION TUBE STOPPED HALFWAY, SO THE TRACHEAL TUBE WAS REMOVED AND A NEW TRACHEAL TUBE WAS INSERTED.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 18909186 ↗

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-