CARDINAL HEALTH SU130-404DRecalls & reported problems
Cardinal Health 200, LLC · JP 3-SPRING RES W/19FR PVC DRAIN/TR · Class 1 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10192253016444), received between Apr 29, 2021 and May 1, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
- Difficult to Remove1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Muscle Weakness/Atrophy1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 1, 2025Obstruction of Flow; Obstruction of Flow
CUSTOMER REPORTED THAT THEIR UNIT HAS BEEN HAVING ISSUES WITH THE CARDINAL HEALTH¿ JACKSON-PRATT® PVC ROUND DRAIN 3-SPRING RESERVOIR KIT WITH TROCAR, 400ML, 19FR FOR OVER A YEAR. THEY ARE JUST NOW REPORTING IT BECAUSE THEY DIDN'T KNOW WHO TO REPORT TO. THE DRAIN IS CLOGGING IN THE TUBING EVERY 12 HOURS POST-OPERATIVELY. THEY ARE HAVING TO MANUALLY UNCLOG THEM. THEY HAVE HAD PATIENTS START BLEEDING BUT NO FURTHER INFORMATION WAS PROVIDED TO CARDINAL, AND ONE PATIENT HAD A DROP FOOT DUE TO THE DRAIN AND HAD TO GO BACK INTO SURGERY. THE ISSUE WAS REPORTED TO THE OR MANAGER AT THE TIME. THEY DID NOT KEEP THE DRAIN(S) THAT WERE CAUSING THE ISSUE AND DO NOT HAVE SAMPLES OR LOT NUMBERS. THEY CHANGED TO A NEW TYPE OF DRAIN - THE BULB JP DRAIN FROM CARDINAL. EXACT EVENT DATE IS UNKNOWN.
Patient problems: Muscle Weakness/Atrophy
MAUDE report 21946499 ↗MalfunctionJun 10, 2021Break; Break
CUSTOMER REPORTED USING A HEMOVAC SUCTION DRAIN RESERVOIR DURING LEFT KNEE PROCEDURE. REPORTEDLY, THE DRAIN WAS BEING REMOVED PER USUAL ROUTINE POSTOPERATIVE ORDER 22 HOURS LATER WHEN END OF DRAIN BROKE OFF IN PATIENT. BROKEN PIECE SURGICALLY REMOVED AND PATIENT ROUTINELY DISCHARGED THE NEXT DAY. THEY WERE ABLE TO WRAP UP THE DRAIN IN A BIOHAZARD BAG TO RETURN FOR INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11979986 ↗InjuryApr 29, 2021Break; Difficult to Remove; Break; Difficult to Remove
CUSTOMER REPORTED THERE WAS RESISTANCE DURING REMOVAL OF HEMOVAC DRAIN AND IT BROKE OFF LEAVING A PIECE INSIDE OF THE PATIENT¿S LUMBAR AREA. SURGICAL PROCEDURE REQUIRED TO REMOVE THE BROKEN PIECE AND IT WAS RETRIEVED WITHOUT FURTHER INCIDENT. PATIENT DOING FINE. THE PRODUCT NUMBER PROVIDED IS (44-2592 OR 44-2593) FOR RESERVOIR KIT WITH PVC ROUND DRAIN 400 ML JACKSON-PRATT WOUND DRAINAGE. THE NUMBERS PROVIDED ARE NOT PRODUCT NUMBERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11750006 ↗
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- CARDINAL HEALTH SU130-402DCardinal Health 200, LLC · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED1 recall1 report
- CARDINAL HEALTH SU130-475Cardinal Health 200, LLC · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED1 recall0 reports
- CARDINAL HEALTH SU130-403DCardinal Health 200, LLC · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED1 recall0 reports
- NA 1A8504Baxter International Inc. · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED50 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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