SLX Hemo-Cath® MC101243Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00884908083002), received between Mar 20, 2018 and Dec 19, 2022 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (13 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 16, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2022Leak/Splash; Leak/Splash

  HOME VISIT TO DO INITIAL DRESSING CHANGE 24 HOURS POST INSERTION FOR CVAD. BUBBLES NOTED IN BOTH LUMENS OF CVAD. CLIENT CALLED CCI AND THEY INFORMED HIM THE BUBBLES WILL BE ASPIRATED AT HIS NEXT MAINTENANCE/FLUSH. LINE REMOVED FOR SUSPECTED OBSTRUCTION OF THE DISTAL (BLUE) LUMEN. WITH RESPECT TO THE BLUE LUMEN, ATTEMPTS TO WITHDRAW BLOOD INTO THE SYRINGE WERE UNSUCCESSFUL. APPROXIMATELY 10 CC OF OMNIPAQUE WERE INJECTED, WHICH SWIFTLY OPACIFIED THE CATHETER. ALTHOUGH SOME FREE FLOW OF CONTRAST MEDIA OCCURRED, ACCUMULATION WAS OBSERVED AROUND THE CATHETER TIP, CONFIRMING OBSTRUCTION BY A ONE- WAY FLAP/VALVE MECHANISM. WITH RESPECT TO THE RED LUMEN, BLOOD WITHDRAWAL WAS NORMAL AND THE CATHETER FLUSHED FREELY. CATHETER REMOVAL AND REPLACEMENT WERE SUGGESTED AND COMPLETED - SAMPLE NOT RETAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16003420 ↗
• MalfunctionDec 15, 2022Leak/Splash; Leak/Splash

  10-12 BUBBLES IN CLEAR PORTION OF BROVIAC LINE (BETWEEN THE CLAMPS AND THE INSERTION SITE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15987016 ↗
• MalfunctionDec 15, 2022Leak/Splash; Leak/Splash

  AIR IN CVC LINE, NO BLOOD RETURN OR ABLE TO FLUSH AFTER TAKING AIR OUT. ALTEPLASE ADMINISTERED TO LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15986995 ↗
• MalfunctionDec 15, 2022Leak/Splash; Leak/Splash

  ARRIVED IN THE HOME TO DO CVAD MAINTENANCE. APPEARED TO BE EITHER 100% AIR OR 100% FLUID. NO AIR BUBBLES SEEN. WRITER REMOVED THE CURRENT CAP, THEN ATTACHED FLUSH SYRINGE WITH NEW PRIMED CAP AND WRITER PULLED BACK. WRITER NOTED AIR COME INTO THE SYRINGE WITH NO RESISTANCE AND THEN SMALL FLUID WITH AIR IN BETWEEN. CLIENT STATES HE ALSO HAD AIR IN HIS LINE LAST WEEK AND HAD TO GO INTO CCI FOR MAINTENANCE. LINE REMOVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15986956 ↗
• MalfunctionNov 1, 2022Air/Gas in Device; Air/Gas in Device

  LARGE AIR BUBBLE NOTED IN THE BLUE LUMEN EXTENSION OF CLIENT'S DUAL LUMEN CENTRAL LINE. CATHETER REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15708705 ↗
• MalfunctionJul 15, 2021Air/Gas in Device; Air/Gas in Device

  AIR BUBBLES WERE NOTED IN THE ARTERIAL EXTENSION LINE. CATHETER REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177235 ↗
• MalfunctionJul 15, 2021Air/Gas in Device; Air/Gas in Device

  AIR BUBBLES WERE NOTED IN BOTH EXTENSION LINES. CATHETER REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177178 ↗
• MalfunctionJul 15, 2021Air/Gas in Device; Air/Gas in Device

  AIR BUBBLES WERE NOTED IN THE VENOUS EXTENSION LINE. CATHETER REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177082 ↗
• MalfunctionJul 15, 2021Air/Gas in Device; Air/Gas in Device

  AIR BUBBLES WERE NOTED IN THE ARTERIAL EXTENSION LINE. CATHETER REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12176900 ↗
• MalfunctionJul 15, 2021Air/Gas in Device; Air/Gas in Device

  AIR BUBBLES WERE NOTED IN BOTH EXTENSION LINES. CATHETER REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12176748 ↗
• MalfunctionJul 15, 2021Air/Gas in Device; Air/Gas in Device

  AIR BUBBLES WERE NOTED IN BOTH EXTENSION LINES. AIR WAS REMOVED WITH A SYRINGE. NO FURTHER EVIDENCE OF AIR FOLLOWING PROCEDURE. CATHETER REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12176591 ↗
• MalfunctionJul 15, 2021Air/Gas in Device; Air/Gas in Device

  AIR BUBBLES WERE NOTED IN THE ARTERIAL EXTENSION LINE. ONE WEEK LATER AIR BUBBLES NOTED IN BOTH EXTENSION LINES. CATHETER REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12176482 ↗
• MalfunctionJul 12, 2021Leak/Splash; Leak/Splash

  AIR BUBBLES NOTED TO BOTH LUMENS OF CVAD ABOVE AND BELOW CLAMP. LINE LAST FLUSHED 48 HOURS AGO, WITH NO ACCESS TO CVC AFTER FLUSHING. NO CRACKS, LEAKS OR ISSUES NOTED TO INTEGRITY OF LINE. LINE CARE PROVIDED INCLUDING REMOVAL OF AIR, FLUSHING AS PER PROTOCOL. LINE REMAINS INSITU AND TO BE MONITORED FOR FURTHER AIR LEAKS. STAFF HAVE IDENTIFIED THAT THE CAPS THAT ARE PROVIDED IN THE KIT ARE THE ISSUE. THEY HAVE SINCE SWITCHED TO A DIFFERENT CAP WITH NO FURTHER AIR IN-LINE CONCERNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12154610 ↗
• MalfunctionJul 12, 2021Leak/Splash; Leak/Splash

  CLIENT'S CVAD HAD MULTIPLE LARGE AIR BUBBLES IN BOTH LINES THAT HAD FORMED WITHIN 24 HOURS. CVAD - NEW ONE PUT IN THE NEXT DAY, CLIENT STATED THAT IT WAS BEING SAVED TO ASSESS FOR DEFECTS AND A DIFFERENT BRAND WAS USED FOR THE NEW CVAD. PROBLEM IS REOCCURRING WITH NEW CVAD HOWEVER. CONTINUING TO FOLLOW UP WITH EDUCATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12154509 ↗
• MalfunctionJul 12, 2021Leak/Splash; Leak/Splash

  PATIENT CALLED BMT OFFICE AFTER NOTICING SMALL BUBBLES TO CVAD LINE. WAS INSTRUCTED PREVIOUSLY TO NOTIFY BMT IF AIR/BUBBLES IN LINE WAS OBSERVED AGAIN. ONE SMALL BUBBLE (APPROX. 3 MM) NOTED ABOVE CAP TO RED LUMEN OF CVAD. ONE SLIGHTLY LARGER BUBBLE (APPROX. 5 MM) NOTED ABOVE CLAMP TO BLUE LUMEN. BOTH LUMENS OF CVAD FLUSHED WELL WITH NORMAL SALINE, WITH EXCELLENT BRISK BLOOD RETURN NOTED UPON ASPIRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12153863 ↗
• MalfunctionMay 17, 2021Air/Gas in Device; Air/Gas in Device

  AN AIR BUBBLE WAS NOTED IN EACH EXTENSION OF THE HEMO-CATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11837660 ↗
• MalfunctionApr 30, 2021Air/Gas in Device; Air/Gas in Device

  PATIENT WAS IMPLANTED WITH THE HEMO-CATH CATHETER ON (B)(6) 2021. ON (B)(6) 2021 THE DEVICE WAS REMOVED AND REPLACED DUE TO AIR IN THE LINE. PATIENT REPORTS AIR IN THE LINE OF THE SECOND DEVICE AS WELL. A HOME CARE NURSE REPORTS REMOVING APPROXIMATELY 1.5 MLS OF AIR FROM THE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752033 ↗
• MalfunctionJan 19, 2021Leak/Splash; Leak/Splash

  CATHETER WAS INSERTED WITHOUT INCIDENT ON (B)(6) 2021. PATIENT PRESENTED FOR DIALYSIS ON (B)(6) 2021. TOWARD THE END OF TREATMENT, THE NURSE NOTICED A PINHOLE IN THE CLEAR LUER OF THE VENOUS (BLUE) LUMEN. THIS HOLE EITHER INTRODUCED AIR INTO THE LUMEN OR LEAKED TINY AMOUNTS OF BLOOD DEPENDING ON WHETHER THE CATHETER WAS FLUSHED OR ASPIRATED. CATHETER WAS EXCHANGED OVER THE WIRE FOR A NEW CATHETER ON SAME DAY. THE PATIENT PRESENTED FOR DIALYSIS ON (B)(6) 2021 WHEN ANOTHER PINHOLE WAS IDENTIFIED BY ANOTHER NURSE, THIS TIME ON THE ARTERIAL (RED) LUMEN. PATIENT WAS NOT PREPARED TO UNDERGO SEDATION/ANESTHESIA FOR ANOTHER EXCHANGE. OUT OF CONCERN THAT THIS MAY OCCUR AGAIN WITH ANOTHER CATHETER, THE DOCTOR IDENTIFIED THE HOLE AND SEALED IT WITH CYANOACRYLATE, WHICH WAS ALLOWED TO DRY AND REINFORCED WITH A CLEAR ADHESIVE FILM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11194457 ↗
• MalfunctionNov 13, 2020Leak/Splash; Leak/Splash

  CATHETER DAMAGE DISCOVERED IN DIALYSIS CLINIC. UNABLE TO RUN DIALYSIS DUE TO "PINHOLE" IN BLUE CATHETER, DISTAL TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10835826 ↗
• MalfunctionNov 13, 2020Leak/Splash; Leak/Splash

  CATHETER DAMAGE DISCOVERED IN DIALYSIS CLINIC. UNABLE TO RUN DIALYSIS DUE TO "PINHOLE" IN BLUE CATHETER, DISTAL TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10835724 ↗
• MalfunctionOct 22, 2020Leak/Splash; Leak/Splash

  DURING A CONTRAST STUDY, A HOLE IN THE LINE WAS DETECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10721933 ↗
• MalfunctionApr 24, 2020Backflow; Backflow

  WHEN CATHETER IS RUN IN THE NORMAL DIRECTION ARTERIAL TO VENOUS, AT THAT START OF DIALYSIS SALINE IS ASPIRATED FROM THE ARTERIAL LINE THAT IS ONLY SLIGHTLY BLOOD TINGED. IT APPEARS AS IF THERE IS A COMMUNICATION BETWEEN THE ARTERIAL AND VENOUS LUMENS. THE CATHETER SEEMS TO WORK WHEN RUN IN REVERSE, THOUGH WITH SIGNIFICANT RECIRCULATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9996461 ↗
• InjuryJan 23, 2020Leak/Splash; Leak/Splash

  DURING DIALYSIS IT WAS NOTED THAT PATIENT WAS BLEEDING FROM THE INSERTION SITE. PATIENT LOST TWO (2) UNITS OF BLOOD. CATHETER WAS REMOVED AND IT WAS NOTED THAT THERE WAS A HOLE BETWEEN THE LUMENS.

  Patient problems: Blood Loss

  MAUDE report 9621435 ↗
• MalfunctionMar 20, 2018Leak/Splash; Leak/Splash

  NOTICED A LEAK WHILST ON DIALYSIS. CVC KEPT IN SITU AND OTHER LUMEN USED UNTIL FISTULA MATURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7352378 ↗