ARROW IPN920475Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10801902195132), received between Jun 7, 2022 and Mar 19, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 10, 2026Open, Classified

   16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

   Z-2157-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT "ON (B)(6) 2026, DURING PRIMING AFTER COMPLETION OF LONG-TERM HEMODIALYSIS CATHETER INSERTION AT THE HEMODIALYSIS ROOM OF (B)(6) HOSPITAL, BLEEDING OCCURRED AT THE COMPRESSION CAP CONNECTION. INSPECTION REVEALED CRACKING ON THE COMPRESSION CAP.AFTER CONFIRMED WITH THE CUSTOMER. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE.NO MEDICAL INTERVENTION WAS REQUIRED.THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24636721 ↗
• MalfunctionDec 13, 2022Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT "DURING THE INSERTION OF THE DILATOR, THEY ENCOUNTERED RESISTANCE TO INTRODUCTION. AS THEY PULLED OUT THE ENTIRE DEVICE, THEY NOTICED THAT THE GUIDE-WIRE WAS BENT IN SEVERAL POINT." NO PATIENT HARM WAS REPORTED. A NEW GUIDEWIRE WAS USED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15973524 ↗
• MalfunctionAug 23, 2022Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS "THERE WAS A BLOOD LEAK AT THE LEVEL OF THE JUNCTURE HUB. IT MADE US THINK THERE COULD BE A SEPARATION OF THE CATHETER FROM THE JUCTURE HUB.". IT WAS REPORTED THERE WAS NO CONSEQUENCE FOR THE PATIENT. THE CATHETER WAS REMOVED AND A NEW ONE WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15280359 ↗
• MalfunctionAug 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: "INCIDENT HAPPENED ON (B)(6) 2022, INVOLVED A FEMALE PATIENT. THE PATIENT HAD THE DIALYSIS CATHETER INSERTED ON 18 JULY. THE DOCTOR COULD NOT DO HIS DIALYSIS BECAUSE THE CATHETER WAS LEAKING UNDER THE SKIN ALONG THE PATH OF THE CATHETER LINE. THE PATIENT WAS SENT BACK TO THE OPERATING ROOM ON (B)(6) AND HAD THE CATHETER REMOVED AND HAD A DIALYSIS CATHETER "PALINDROME" FROM BRAND "MEDTRONIC" THIS TIME."

  Patient problems: Insufficient Information

  MAUDE report 15213038 ↗
• MalfunctionJun 23, 2022Air/Gas in Device; Air/Gas in Device

  CUSTOMER COMPLAINT REPORTS "DURING BLOOD SAMPLE, PRESENCE OF AIR IN THE CONNECTOR WAS OBSERVED. THIS INCIDENT IS DUE TO THE FACT THAT THE CONNECTOR WAS INCORRECTLY SCREWED ON DURING INSERTION OF THE CATHETER BECAUSE THE SCREW THREAD OF THE JUNCTURE HUB HAD A DEFECT. THUS IT WAS IMPOSSIBLE TO SCREW IT TO THE END." IT WAS REPORTED THE DEVICE WAS CHANGED. THERE WAS NO HARM OR CONSEQUENCE FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14794173 ↗
• MalfunctionJun 7, 2022Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED IT WAS NOT EASY TO REMOVE THE GUIDEWIRE BECASUE A KNOT FORMED AT ITS DISTAL END. RESISTANCE WAS FELT WHEN THE TIP OF THE J-WIRE REACHED THE TIP OF THE CATHETER AND THE KNOT PREVENTED THE GUIDEWIRE FROM SLIDING INSIDE THE CATHETER. THE GUIDEWIRE AND CATHETER WERE REMOVED TOGETHER AND A TEMPORARY CATHETER WAS PLACED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14625129 ↗