CARDINAL HEALTH SU130-1334Recalls & reported problems
Cardinal Health 200, LLC · T-TUBE 19FR SILICONE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00192253022462), received between Sep 21, 2026 and Sep 23, 2026 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Obstruction of Flow” (4 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
- Obstruction of Flow4
Patient problems
- Obstruction/Occlusion3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Obstruction of Flow
Patient problems: Obstruction/Occlusion
MAUDE report 50872624 ↗InjurySep 23, 2026Obstruction of Flow
Customer reported that they had a patient within the last month who had to be brought back to surgery due to these tubes malfunctioning. The customer stated that the original surgery date with tube placement was (b)(6) 2026. Patient was taken to IR when the drain malfunctioned for tube injection with conscious sedation on (b)(6)2026. Patient was brought back to OR for Laparoscopic tube placement with general anesthesia. A different tube was placed during this case. Patient was discharged from the hospital on (b)(6) 2026 and stable.
Patient problems: Obstruction/Occlusion
MAUDE report 50872255 ↗MalfunctionSep 21, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848033 ↗InjurySep 21, 2026Obstruction of Flow
Patient problems: Obstruction/Occlusion
MAUDE report 50847950 ↗
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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