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The VitalCough®System
HILL-ROM SERVICES PTE. LTD. · Model M06828 · UDI-DI 00887761997264
10
510(k) clearances
189
Adverse events (11 deaths)
10
Recalls
29
Facilities
Description
Respiratory Care
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-21 | Baxter Healthcare Corporation | There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the |
| 2026-05-21 | Baxter Healthcare Corporation | There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the |
| 2026-05-21 | Baxter Healthcare Corporation | There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the |
| 2026-05-21 | Baxter Healthcare Corporation | There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the |
| 2026-02-18 | Baxter Healthcare Corporation | Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen l |
| 2024-09-16 | Percussionaire Corporation | As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy was being given with specific medication through the nebulizer |
| 2024-05-30 | Baxter Healthcare Corporation | Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow |
| 2024-05-30 | Baxter Healthcare Corporation | Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow |
| 2022-04-26 | Baxter Healthcare Corporation | There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment. |
| 2022-04-26 | Baxter Healthcare Corporation | There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.