Percussionaire A50094-DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00849436000259), received between Jun 3, 2016 and Sep 30, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K905235); 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.

Recalls naming this device

1. Dec 23, 2024Open, Classified

   Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.

   Z-0960-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanical Problem; Particulates

  On (b)(6) 2026, Percussionaire was notified that while a ventilated NICU patient was receiving therapy, a piece of blue particulate was identified in the suction port of the patient circuitry. The user ceased use of the breathing circuit on the patient, and replaced it with a different breathing circuit. No patient harm or injury was reported by the customer. As this device malfunction occurred while in use on a ventilated patient, this event is being reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946051 ↗
• MalfunctionNov 22, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED BY A CUSTOMER THAT DURING TREATMENT ON A PATIENT, THE INTERNAL COMPONENT THAT AIDS IN PROVIDING PULSATION WITHIN THE PHASITRON BREATHING CIRCUIT WAS STICKING, INHIBITING PROPER TREATMENT. THE PATIENT EXPERIENCED SLIGHT DESATURATION. NO ADDITIONAL PATIENT INFORMATION PROVIDED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 20758020 ↗
• InjuryJan 24, 2024Infusion or Flow Problem; Infusion or Flow Problem

  A CUSTOMER COMPLAINT WAS RECEIVED BY PERCUSSIONAIRE'S DISTRIBUTOR AFTER THE CUSTOMER WAS NOTIFIED OF AN URGENT FIELD SAFETY CORRECTIVE ACTION. IN RESPONSE TO THE PERCUSSIONAIRE FIELD SAFETY NOTIFICATION, THE CUSTOMER STATED ON (B)(6) A NICU PATIENT EXPERIENCED A PNEUMOTHORAX AFTER USING THE PHASITRON DEVICE. THE CUSTOMER NOTED THAT THE DEVICE SEEMED TO BE MAKING A HIGH PITCHED NOISE AND EXHIBITING HIGH PRESSURES, DESPITE ATTEMPTING TO REDUCE THE PRESSURE OUTPUT.

  Patient problems: Pneumothorax

  MAUDE report 18576339 ↗
• MalfunctionJun 3, 2016Material Separation; Device Operates Differently Than Expected

  PHASITRON SEPARATED AT WELD WHILE IN USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5699445 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K905235. One submission often covers many models, so check the product and lot details in each record.

• Z-0693-2024 · Mar 28, 2023 · Open, Classified
  Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
• Z-0259-2024 · Sep 14, 2020 · Completed
  Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.