ARROW IPN920377Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902194197), received between Mar 23, 2023 and Mar 23, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT "WHEN THE ANAESTHETIST TRIED TO PULL THE INLAY (DILATOR) OUT OF THE SHEATH AFTER INSERTING IT INTO THE VESSEL, THE CONE OF THE DILATOR BROKE OFF QUITE SMOOTHLY AND THE DILATOR REMAINED INSIDE THE SHEATH. FORTUNATELY, THE DILATOR DID NOT SLIDE FURTHER INTO THE VESSEL, SO WE WERE ABLE TO RETRIEVE IT TOGETHER WITH THE SHEATH. AFTERWARDS, WE LAID A NEW SHEATH OF THIS TYPE. THERE WERE NO INCIDENTS THERE. UNFORTUNATELY, THE PRODUCT IN QUESTION WAS ACCIDENTALLY DISCARDED AND IS NOT AVAILABLE FOR FURTHER INVESTIGATIONS." THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16598668 ↗