CARDINAL HEALTH ASU1220Recalls & reported problems
Cardinal Health 200, LLC · Trumpet Valve, Hydroline, No Probe, Single Spike · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10630140169779), received between Apr 27, 2018 and May 10, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Aspiration Issue” (1 report).
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.
Most reported problems
Device problems
- Aspiration Issue1
- Failure to Read Input Signal1
- Sticking1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 10, 2018Sticking
THE SUCTION BUTTON KEPT GETTING STUCK DURING A PROSTATECTOMY PROCEDURE. NO INJURY TO PATIENT, DOCTOR COMPLETED THE PROCEDURE WITHOUT INCIDENT WITH ANOTHER DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7503225 ↗MalfunctionApr 27, 2018Failure to Read Input Signal; Aspiration Issue
IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A LAP CHOLE ON AND FEMALE PATIENT WHEN THE TRUMPET VALVE WOULD NOT SUCTION. THE RED BUTTON IS EITHER STICKING WHEN PUSHING DOWN OR ONCE IT¿S BEEN PUSHED. THE PATIENT WAS NOT COMPROMISED DURING THE PROCEDURE AND ANOTHER TRUMPET VALVE WAS PULLED FROM THE SHELF TO FINISH THE CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7468110 ↗
Other CATHETER, IRRIGATION devices
- Navarre Opti-Drain NOD8LPTBard Access Systems, Inc. · CATHETER, IRRIGATION901 reports
- Navarre NNU8LPTBard Access Systems, Inc. · CATHETER, IRRIGATION736 reports
- BLAKE 2227Ethicon Inc. · CATHETER, IRRIGATION331 reports
- Navarre NNU6LPTBard Access Systems, Inc. · CATHETER, IRRIGATION211 reports
- Navarre Opti-Drain NOD10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION178 reports
- Navarre NNU10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION127 reports
- BLAKE 2233Ethicon Inc. · CATHETER, IRRIGATION114 reports
- Vasoshield VH-5001Maquet Cardiovascular LLC · Catheter, Irrigation1 recall27 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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