ARROW IPN030318Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801902102775), received between Feb 1, 2021 and Feb 1, 2021 — classified as 2 malfunctions.

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

• MalfunctionFeb 1, 2021Material Separation; Material Separation

  THE COMPLAINT IS REPORTED AS: THE PHYSICIAN TRIED TO PASS THE GUIDEWIRE THROUGH THE INTRODUCER NEEDLE AND IT "GOT STUCK". AT THE THIRD ATTEMPT TO INTRODUCE THE CATHETER IN THE PATIENT'S ARM THE GUIDEWIRE "BREAKS AND FRACTURES". THE PHYSICIAN WITHDREW THE GUIDEWIRE AND INTRODUCER NEEDLE. IT WAS REPORTED THE PATIENT HAD "MULTIPLE PUNCTION AT THE SKIN AND LOCAL INFLAMMATION". NO MEDICAL INTERVENTION WAS REQUIRED. ANOTHER DEVICE WAS PLACED WITHOUT PROBLEM. THE PATIENT'S CONDITION WAS REPORTED AS "CRITICAL" UNRELATED TO THE DEVICE ISSUE.

  Patient problems: Inflammation

  MAUDE report 11258710 ↗
• MalfunctionFeb 1, 2021Material Deformation; Material Deformation

  THE GUIDEWIRE WAS "SEVERELY BENDED INSIDE THE PACKAGE". NO PATIENT INVOLVEMENT REPORTED. ANOTHER DEVICE WAS OBTAINED FOR PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11257908 ↗