CARDINAL HEALTH ASU1200Recalls & reported problems
Cardinal Health 200, LLC · Trumpet Valve, Hydroline, 5mm x 33cm Probe, Single Spike · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10630140169694), received between Feb 6, 2018 and May 16, 2018 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Partial Blockage” (2 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.
Most reported problems
Device problems
- Partial Blockage2
- Aspiration Issue1
- Device Operates Differently Than Expected1
- Sticking1
- Suction Problem1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Information2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2018Suction Problem
THE SUCTION BUTTON REMAINS BLOCKED, UNABLE TO STOP THE SUCTION. THE INTERVENTION WAS A CHOLECYSTECTOMY PROCEDURE. HEALTHCARE PROFESSIONAL HAD TO MANUALLY UNBLOCK THE ASPIRATION VALVE TO STOP SUCTION. IT CAUSED IMPROPER TRUMPET HANDLING, LOSS OF PNEUMOPERITONEUM, WASTE OF TIME (NEEDED TO WAIT FOR BODY TO BE RE-INFLATED), IMPROPER MOVEMENT DURING TRUMPET VALVE USE AND DIFFICULTIES FOR THE USER TO CONCENTRATE ON THE PROCEDURE. RISK OF IATROGENIC WOUND DURING USE. NO CONSEQUENCE FOR PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7518905 ↗MalfunctionApr 11, 2018Sticking; Aspiration Issue
AFTER SEVERAL USES, THE SUCTION RED SWITCH REMAINS DEPRESSED CAUSING ASPIRATION TO CONTINUE. THIS CAUSES A LOSS OF PNEUMOPERITONEUM AND A SLOWDOWN OF THE PROCEDURE.
Patient problems: No Information
MAUDE report 7422084 ↗MalfunctionApr 5, 2018Partial Blockage
IT WAS NOTICED THE SUCTION BUTTON REMAINS BLOCKED AND SUCKS THE PNEUMOPERITONEUM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7400165 ↗MalfunctionMar 21, 2018Partial Blockage
THE CUSTOMER REPORTED BLOCKING OF THE VALVE WITH THE CLINICAL CONSEQUENCE OF CONTINUOUS ASPIRATION WITH GAS ASPIRATION. THE ACTION THEY TOOK WAS TO CHANGE THE TRUMPET VALVE. NO KNOWN PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7360129 ↗MalfunctionFeb 6, 2018Device Operates Differently Than Expected
THE SUCTION TUBE WITH TRUMPET WAS BEING USED DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY. THE RED BUTTON OF THE TRUMPET VALVE DID NOT WORK CORRECTLY.
Patient problems: No Information
MAUDE report 7245415 ↗
Other CATHETER, IRRIGATION devices
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- 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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