ARROW CS-15232-VFIERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902154184), received between Apr 29, 2026 and Jun 12, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Premature Separation

  IT WAS REPORTED THAT DURING THE INSERTION OF A CHRONIC HEMODIALYSIS CATHETER (CHDC), WHEN ATTEMPTING TO INSERT THE PEEL-AWAY SHEATH AND DILATOR INTO THE VESSEL, THE SHEATH PREMATURELY SPLIT LONGITUDINALLY. ADDITIONAL INFORMATION RECEIVED FROM THE USER FACILITY INDICATED THAT PRIOR TO DILATION, AN APPROXIMATELY 1 CM SKIN INCISION WAS MADE OVER THE SPRING WIRE GUIDE (SWG), AND BLUNT DISSECTION WAS PERFORMED USING CLAMPS TO FACILITATE TUNNELING OF THE CHDC. THE DILATORS AND PEEL-AWAY SHEATH WERE ADVANCED IN THE USUAL MANNER USING A GENTLE TWISTING MOTION. HOWEVER, IN THIS CASE, THE PEEL-AWAY SHEATH SPLIT IMMEDIATELY UPON ATTEMPTED INSERTION, PREVENTING ADVANCEMENT OR INITIATION OF THE TWISTING MOTION. THE AFFECTED DEVICE WAS REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A REPLACEMENT DEVICE. THE EVENT RESULTED IN AN APPROXIMATE 10-15 MINUTE DELAY IN THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT OTHER THAN THE PROCEDURAL DELAY. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED BEYOND THAT DESCRIBED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25491517 ↗
• MalfunctionApr 29, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT "DURING INITIAL INSERTION, LEAKAGE WAS OBSERVED FROM THE JUNCTION HUB OF THE CHRONIC HEMODIALYSIS CATHETER WHILE THE CATHETER WAS BEING FLUSHED." THERE WAS NO REPORT OF ANY PATIENT INJURY, HARM OR HEALTH CONSEQUENCES. THE CATHETER WAS REMOVED AND A NEW CATHETER WAS INSERTED. THE PATIENT'S CURRENT CONDITION WAS REPORTED AS "GOOD".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25029772 ↗