ARROW IPN030333Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801902102829), received between Jul 12, 2024 and Jan 9, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 16, 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.

• InjuryJan 9, 2025Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  IT WAS REPORTED THAT "CATHETER FRAGMENTS LEFT IN PATIENT'S BODY AFTER REMOVAL". ADDITIONAL INFORMATION REPORTED THAT A CT CHECK (INCLUDING INSPECTION OF FRAGMENTS) WAS PERFORMED, AND A HAEMATOMA WAS REMOVED. THE RETRIEVAL OF THE FRAGMENT WAS UNSUCCESSFUL. THE CONDITION OF THE PATIENT IS REPORTED TO BE HAEMODYNAMICALLY STABLE.

  Patient problems: Foreign Body In Patient; Hematoma

  MAUDE report 21110676 ↗
• MalfunctionJul 12, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "PRESENCE OF KINKING IN THE GUIDE WIRE." THE PATIENT WAS REPORTED AS FINE, THERE WAS NO PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19728418 ↗
• MalfunctionJul 12, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "PRESENCE OF KINKING IN THE GUIDE WIRE." THE PATIENT WAS REPORTED AS FINE, THERE WAS NO PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19728334 ↗