Parker Flex-Tip H-PFHV-80Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10749065011800), received between Sep 18, 2026 and Sep 18, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Patient-Device Incompatibility

  Patient in EP "[electrophysiology]" for Watchman procedure on "[redacted]". Per documentation no complications during intubation or recovery. Anes induction at 1258, Anes end at 1359. Patient arrived to CCL "[cardiac cath lab]" recovery at 1400. Recovery was uneventful and patient was about to be discharged to home (in a wheelchair) when patient then complained of SOB "[shortness of breath]" and a lump in the throat and developed facial swelling. CXR showed: 1. Small right apical pneumothorax. 2. Pneumomediastinum and soft tissue gas throughout the lower neck and chest wall. 3. Patchy opacities throughout both lungs, most prominent at the right lung base, compatible with multifocal pneumonia. 4. Loop recorder overlies the left heart. Patient resp status continued to decline and decision was made to intubate patient. Patient transferred to ICU where bedside bronch was completed and a 1cm tracheal tear was found in the main carina. Patient was taken operating room for repair.

  Patient problems: Pneumothorax; Stacking Breaths; Swelling/ Edema

  MAUDE report 50818324 ↗