ARROW IPN920486Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902195248), received between Dec 13, 2022 and Dec 15, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (1 report).

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

• MalfunctionDec 15, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THE CATHETER EMPTIED DESPITE THE CLAMPING. THERE WAS NO CLINICAL CONSEQUENCE FOR THE PATIENT. NO MEDICAL INTERVENTION WAS REQUIRED. IT WAS REPORTED "THE GREEN JOINT WAS PROPERLY CONNECTED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15992231 ↗
• 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 INTRODUCER, THEY ENCOUNTERED RESISTANCE TO INTRODUCTION. AS THEY PULLED OUT THE ENTIRE DEVICE, THEY NOTICED THAT THE GUIDE-WIRE WAS BENT." NO PATIENT HARM WAS REPORTED. A NEW DEVICE WAS USED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15974440 ↗