CARDINAL HEALTH SU130-0323 (UDI 10192253022247)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10192253022247), received between May 24, 2024 and May 15, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Material Separation

  PATIENT HAD AN ELECTIVE LAMINECTOMY AND FUSION SURGERY. PATIENT RETURNED TO THE HOSPITAL POST PROCEDURE AFTER BEING DISCHARGED. CT IMAGING REVEALED A SURGICAL DRAIN FRAGMENT IN THE LAMINECTOMY BED REGION WITH ITS PROXIMAL END IN THE SUBCUTANEOUS SOFT TISSUES JUST BENEATH THE SKIN. PATIENT RETURNED TO SURGERY FOR REMOVAL OF RETAINED DRAIN FRAGMENT. A SURGICAL DRAIN/DRAIN FRAGMENT IS SUGGESTED IN THE REGION OF THE LAMINECTOMY BED WITH ITS PROXIMAL END IN THE SUBCUTANEOUS SOFT TISSUES JUST BENEATH THE SKIN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25194342 ↗
• InjuryMar 24, 2026Material Separation

  THE CUSTOMER REPORTED THAT THE DRAIN BROKE OFF INSIDE THE PATIENT. INITIAL LUMBAR SURGERY WAS PERFORMED ON (B)(6) 2026 WITH A DRAIN PLACEMENT. ON (B)(6) 2026, SURGERY FOR EXPLORATION POST SURGICAL LUMBAR WOUND REPAIR FOR DURAL TEAR WAS PERFORMED. PROVIDER STATED HE REMOVED A PIECE OF RETAINED DRAIN YESTERDAY ON (B)(6) 2026. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24676906 ↗
• InjuryMar 20, 2026Material Separation

  ON (B)(6) 2025, THE PATIENT HAD AN INITIAL SURGERY FOR L5-S1 TLIF. CUSTOMER REPORTED THE DRAIN BROKE OFF AND WAS RETAINED INSIDE THE PATIENT. ON (B)(6) 2025, THE PATIENT WAS BROUGHT BACK TO SURGERY FOR I&D OF LUMBAR WOUND. THE SURGEON DID NOT STATE THAT HE REMOVED ANY RETAINED DRAIN PIECES AND IT IS NOT DOCUMENTED IN THE SPECIMEN PORTION OF THE INTRAOPERATIVE RECORD. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: Foreign Body In Patient

  MAUDE report 24654783 ↗
• InjuryMar 20, 2026Material Separation

  CUSTOMER REPORTED THE DRAIN BROKE OFF INSIDE THE PATIENT. ON (B)(6) 2026, THE PATIENT HAD AN INITIAL SURGERY FOR NERVE MONITORED L3-S1 HEMILAMINECTOMY, LEFT FUSION WITH NAVIGATION. ON (B)(6) 2026, THE PATIENT WAS BOUGHT BACK TO SURGERY FOR REMOVAL OF RETAINED DRAIN THAT BROKE IN THE SURGICAL LUMBAR REGION. SPECIMEN WAS SENT TO THE HOSPITAL LAB. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24654666 ↗
• InjuryMar 20, 2026Material Separation

  CUSTOMER REPORTED THE DRAINS ARE BREAKING OFF INSIDE THE PATIENT. ON (B)(6) 2026, PATIENT HAD AN INITIAL SURGERY FOR NERVE MONITORED LEFT L4 HEMILAMINECTOMY WITH NAVIGATION AND FUSION L4-5. ON (B)(6) 2026, NURSING NOTES STATED THAT SOME RESISTANCE WAS MET ON DRAIN REMOVAL, HOWEVER, JP DRAIN TIP NOT INTACT. THE NURSE WAS UNABLE TO SEE THE TIP IN VIEW. ON (B)(6) 2026, THE PATIENT WAS BROUGHT BACK TO SURGERY FOR REMOVAL OF THE JP DRAIN TIP FROM THE BACK. SPECIMEN SENT TO THE HOSPITAL LAB. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24653286 ↗
• MalfunctionNov 19, 2025Material Separation; Material Separation

  CUSTOMER REPORTED THAT THE DRAIN WAS BEING MILKED WHILE EMPTYING, AND THE DRAIN TUBING BROKE LEADING TO IT NEEDING TO BE REMOVED. DRAIN WAS NOT REPLACED. ONE NURSE EVEN NOTES THE TUBING LOOKED "OFF". WHEN QUESTIONED SHE SAID IT LOOKED WORN, ALMOST LIKE IT WAS OLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597294 ↗
• MalfunctionMay 24, 2024Break; Break

  CUSTOMER REPORTED THAT THE WOUND DRAIN WAS FOUND FRACTURED IN THE MIDDLE DURING A BREAST SURGERY AND WAS REPLACED DURING THAT INITIAL SURGERY. THE PRODUCT WAS CONNECTED WITH SU130-1305 100CC RESERVOIR TO PROCESS WOUND DRAIN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397762 ↗