Extension Set 5C4464PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00085412030555), received between Jun 12, 2018 and Feb 17, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Component Missing

  IT WAS REPORTED THAT THE PULL RING CAPS ON AN UNSPECIFIED QUANTITY OF 12 FOOT EXTENSION SETS WERE MISSING. THE CAPS WERE NOT IN THE OVERPOUCH. THIS WAS IDENTIFIED BEFORE USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24365276 ↗
• MalfunctionAug 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) PATIENT EXTENSION SETS WERE LEAKING FROM AN UNSPECIFIED LOCATION. THIS OCCURRED DURING UNSPECIFIED PROCESS STEPS OF PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8871937 ↗
• MalfunctionJun 12, 2018Cut In Material; Cut In Material

  IT WAS REPORTED THAT THERE WERE SEVERAL SLICES FOUND IN THE TUBING OF A 12-INCH DRAIN EXTENSION SET BEFORE USE. THE PATIENT WAS NOT ABLE TO SPECIFY HOW MANY DEFECTIVE UNITS WERE INVOLVED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7594295 ↗