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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10749065191700), received between Jul 2, 2024 and Aug 1, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED, AUTOMATIC CUFF PRESSURE GAUGE ALARMED FREQUENTLY AND RE-INTUBATION WAS PERFORMED. AFTER CHECKING FOR LEAKS BY DIPPING THE CUFF IN WATER, A PINHOLE-SIZED HOLE WAS FOUND IN THE CUFF. IT WAS ADDITIONALLY REPORTED; AN ANCHOR FAST WAS USED DURING INTUBATION. POSITION CHANGED EVERY 2-3 HOURS TO LEFT AND RIGHT. THE TUBE POSITION WAS CHANGED LEFT OR RIGHT WITH ANCHOR FAST IN USE. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22691740 ↗
• InjurySep 27, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE TUBE WAS INTUBATED INTO THE PATIENT ON (B)(6). ON (B)(6), THE VENTILATOR WAS REMOVED, AND AN ATTEMPT WAS MADE TO EXTUBATE THE PATIENT, BUT THE TUBE COULD NOT BE REMOVED. AT THAT TIME, THE TUBE COULD NOT BE PUSHED IN. SUSPECTING EDEMA, A STEROID WAS ADMINISTERED, AND AFTER A DAY OF OBSERVATION, ANOTHER ATTEMPT WAS MADE ON (B)(6), BUT THE PATIENT COULD NOT BE EXTUBATED. ON (B)(6), THE SURGEON WAS ABLE TO PUSH THE TUBE IN.THE ANESTHESIOLOGY DEPARTMENT CONSULTED WITH THE SURGEON AND OTOLARYNGOLOGY DEPARTMENT, AND ON (B)(6), A TRACHEOTOMY WAS PERFORMED IN THE OP ROOM, AND ONLY THE TIP OF THE TUBE WAS REMOVED FROM THE TRACHEOSTOMY SITE. IN ORDER TO REMOVE THE TUBE TIP, A LARGER INCISION WAS MADE THAN A NORMAL TRACHEOTOMY. WHEN THE TUBE WAS REMOVED, THE PATIENT WAS VENTILATED WITH THE INTUBATED TUBE UP TO THE TRACHEOSTOMY. FROM THE TRACHEOSTOMY, THE END OF THE TUBE WAS FIRST CUT OFF, AND ONLY THE END OF THE TUBE, INCLUDING THE CUFF, WAS REMOVED FROM THE TRACHEOSTOMY SITE. THE TUBE COULD NOT BE PUSHED IN.,

  Patient problems: Swelling/ Edema

  MAUDE report 20328133 ↗
• InjuryJul 2, 2024Leak/Splash; Gas/Air Leak; Leak/Splash; Gas/Air Leak

  THE INFLATING TUBE WAS TORN AND A LEAK WAS OBSERVED FROM THERE. THE PATIENT WAS MOVED TO ICU WHEN A GURGLING SOUND WAS HEARD COMING FROM THE PATIENTS' MOUTH. THE INFLATING TUBE WAS TORN AND A LEAK WAS OBSERVED FROM THERE. THEY CHECKED THE ORAL CAVITY AND FOUND THAT THE SOUND WAS COMING FROM THE TRACHEA.

  Patient problems: Respiratory Insufficiency

  MAUDE report 19658985 ↗