SPLIT CATH®III ASPC40-3TLE.Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884908004281), received between Jun 30, 2021 and Jun 30, 2021 — classified as 1 death.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathJun 30, 2021Break; Restricted Flow rate; Break; Restricted Flow rate

  PATIENT WITH HISTORY OF ADVANCED CHRONIC KIDNEY DISEASE SECONDARY TO MIXED NEPHROLOGY. THE PATIENT WAS ON CHRONIC THERAPY WITH TRANSCAVAL HEMODIALYSIS CATHETER DUE TO LOSS OF MULTIPLE VASCULAR ACCESSES SECONDARY TO CENTRAL VENOUS STENOSIS. PATIENT REQUIRED MANY INTERVENTIONS TO RECONSTITUTE CENTRAL VENOUS FLOW, WHICH FAILED DUE TO THROMBOSIS AND LOSS OF PATENCY. THE MOST RECENT HIGH-FLOW CATHETER REPLACEMENT PROCEDURE WAS VERY DIFFICULT TO HANDLE, PRESENTING DYSFUNCTION AND A LEAK THAT WAS NOT CLEARLY EXPLAINED. ON (B)(6) 2021, VASCULAR SURGEON PERFORMED INTRAVASCULAR FOREIGN BODY EXTRACTION; FAILED TRANSCAVAL PUNCTURE DUE TO HEMATOMA AND LIMITATION FOR THE ADVANCEMENT OF THE GUIDEWIRE; COMPLICATION: RETROPERITONEAL HEMATOMA. IT WAS NOT POSSIBLE TO INSERT A NEW TRANSCAVAL CATHETER. PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT WITH DIAGNOSES: TYPE 3 VENTILATORY FAILURE, RESOLVING HEMORRHAGIC HYPOVOLEMIC SHOCK, TRANSCAVAL FAILED APPROACH POP, RETROPERITONEAL HEMATOMA, UREMIC STATUS, CATHETER-ASSOCIATED BACTEREMIA / E. COLI, MIXED CKD, TYPE 2 DM AND HT. HE RECEIVED HEMODIALYSIS THROUGH A LEFT FEMORAL CATHETER. ON (B)(6), PATIENT DIES. THE CATHETER ITSELF WAS NOT PROVEN TO HAVE L

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Stenosis

  MAUDE report 12091654 ↗