Percussionaire P5-TEERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849436000723), received between Jul 9, 2025 and Jul 9, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Gas/Air Leak” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 18, 2026Open, Classified

   Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation

   Z-3320-2026 · Root cause: Device Design · FDA record ↗

2. Sep 17, 2025Open, Classified

   IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.

   Z-0031-2026 · Root cause: Device Design · FDA record ↗

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.

• InjuryJul 9, 2025Gas/Air Leak; Gas/Air Leak

  ON JUNE 10, 2025, SENTEC WAS NOTIFIED OF AN INCIDENT INVOLVING FOUR NICU PATIENTS WHO EXHIBITED SIGNS OF RESPIRATORY DESCREPENCIES WHILE RECEIVING IPV THERAPY USING THE IN-LINE VALVE (P5-TEE). IT WAS OBSERVED THAT THE PATIENTS WERE RECEIVING ONLY 40-50% OF THE EXHALED VOLUME SET BY THE VENTILATOR, RATHER THAN THE EXPECTED FULL RETURNED VOLUME. THIS DISCREPANCY LED TO THE RETENTION OF CARBON DIOXIDE (CO2) IN THE PATIENTS. THE UNDERLYING CAUSE OF THE CO2 RETENTION WAS NOT INITIALLY KNOWN. AS PART OF TYPICAL IN-LINE VALVE USE, THE PHYSICIAN CONFIRMED THE PRESSURE RELIEF VALVE WAS FULLY CLOSED FOR ALL PATIENT CASES. IN AN EFFORT TO IDENTIFY THE SOURCE OF THE ISSUE, ONE PATIENT WAS REINTUBATED TO RULE OUT COMPLICATIONS RELATED TO THE ENDOTRACHEAL TUBE. THE CO2 RETENTION PERSISTED UNTIL THE IN-LINE VALVE WAS REMOVED, AT WHICH POINT THE PATIENT'S EXHALED TIDAL VOLUMES IMMEDIATELY IMPROVED. DUE TO THE NEED FOR MEDICAL INTERVENTION IN RESPONSE TO THIS EVENT, SENTEC IS SUBMITTING THIS REPORT.

  Patient problems: Respiratory Insufficiency

  MAUDE report 22456912 ↗