The MetaNeb®System C20000NRecalls & reported problems
Hill-Rom Services Pte. Ltd. · Respiratory Care · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887761997134), received between May 14, 2025 and Feb 20, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Crack” (3 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.
Reports received per month
Most reported problems
Device problems
- Crack3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2026Crack
A NEW PROBLEM WAS IDENTIFIED DURING THE DEVICE EVALUATION ASSESSMENT COMPLETED ON 21-JAN-26. THE PATIENT THREE WAY CONNECTOR AND FILTER IS BROKEN. THERE WERE NO PATIENT INVOLVEMENT AND NO INJURY OR ANY IMPACT ON THE PATIENT OR USER RESULTING FROM THIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24401898 ↗MalfunctionJan 12, 2026Crack
(B)(6) NOTIFIED THE DISTRIBUTOR (B)(6) WHICH WAS FURTHER REPORTED TO BAXTER ON (B)(6) 2025. AS PER INFORMATION PROVIDED BASED ON NEW SAMPLE PICTURES, THE FILTER WAS CRACKED, SPECIFICALLY ONE OF THE FILTER¿S BARBS WAS CRACKED. THERE WERE NO PATIENT INVOLVEMENT AND NO INJURY OR ANY IMPACT ON THE PATIENT OR USER RESULTING FROM THIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24048060 ↗MalfunctionMay 14, 2025Crack; Crack
ON (B)(6) 2025 DURING THE INSPECTION OF THE BED BY THE TECHNICIAN, IT WAS NOTED PATIENT CIRCUIT HAD DAMAGE WITH A CRACKED FILTER. THEREFORE, THE AWARE DATE OF THE PATIENT CIRCUIT DAMAGE IS (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22022139 ↗
Other DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT devices
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- Percussionaire F00001-CPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls3 reports
- Percussionaire F00001-C-FRPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls0 reports
- Percussionaire F00001-C-FRPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls0 reports
- Volara System M08085Hill-Rom Services Pte. Ltd. · DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT2 recalls0 reports
- Percussionaire F00001-CPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls0 reports
- Percussionaire F00001-CPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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