ErgoStar CM 40 MP01840Recalls & reported problems
Drägerwerk AG & Co. KGaA · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048675042624), received between Jul 10, 2025 and Jul 10, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Gas/Air Leak” (1 report).
1 FDA recall record name this device's identifier, 1 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.
Reports received per month
Recalls naming this device
- Nov 10, 2025Open, Classified
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Z-0590-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Gas/Air Leak1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2025Material Puncture/Hole; Gas/Air Leak; Material Puncture/Hole; Gas/Air Leak
IT WAS REPORTED THAT SHORTLY AFTER INSTALLATION, THE ERGOSTAR SPLIT AT THE BOUNDARY BETWEEN THE FLEXIBLE AND RIGID PARTS OF THE CORRUGATED TUBE. THE SYSTEM WAS REPLACED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22466924 ↗
Other Connector, Airway (Extension) devices
- Flex Extenders 7-5132Westmed, Inc. · Connector, Airway (Extension)1 recall18 reports
- ErgoStar CM 55 MP01855Drägerwerk AG & Co. KGaA · Connector, Airway (Extension)1 recall10 reports
- ErgoStar CM 45 MP01845Drägerwerk AG & Co. KGaA · Connector, Airway (Extension)1 recall1 report
- Omnistream 011401Oridion Medical 1987 Ltd. · CONNECTOR, AIRWAY (EXTENSION)1 recall0 reports
- ErgoStar CM 60 MP01860Drägerwerk AG & Co. KGaA · Connector, Airway (Extension)1 recall0 reports
- Adaptors/Connectors S6411PWestmed, Inc. · Connector, Airway (Extension)1 recall0 reports
- Portex 66-1991Icu Medical, Inc. · CONNECTOR, AIRWAY (EXTENSION)8 reports
- AirLife 004081Vyaire Medical, Inc. · Connector, Airway (Extension)4 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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