REPAIR KIT RPK-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884908039856), received between Jul 19, 2017 and Feb 2, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2018Leak/Splash; Leak/Splash

  BLOOD LEAKAGE AT THE CONNECTION BETWEEN THE LUER AND THE BLOOD TUBING SET. THIS CAN BE COUNTERACTED BY A TIGHTENING OF THE CONNECTION. THERE HAVE BEEN NO DISCONNECTIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7236872 ↗
• MalfunctionJul 19, 2017Leak/Splash; Leak/Splash

  SUBSEQUENT TO UTILIZATION OF THE CATHETER LUER LOCK DUAL LUMEN DIALYSIS CATHETER REPAIR KIT, THE CATHETER WAS CONNECTED TO THE EXTRA CORPOREAL CIRCUIT AND DIALYSIS TREATMENT WAS INITIATED. AT THIS TIME, FOAM WAS NOTICED IN THE BLOOD CIRCUIT ORIGINATING AT THE HUB. MULTIPLE ATTEMPTS TO TIGHTEN THE CONNECTION WERE UNSUCCESSFUL. THE CATHETER NEEDED TO BE REPLACE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6725877 ↗