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ARROW IPN921163Recalls & reported problems

Teleflex Incorporated · Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902200942), received between May 30, 2023 and May 30, 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

Device problems

  • Material Separation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 30, 2023Material Separation; Material Separation

    THE COMPLAINT IS REPORTED AS: WHEN INSERTING THE ARROW INTRODUCER EVERYTHING WENT WELL. BUT WHEN TRYING THE WITHDRAWAL OF THE "MADRIN/PLASTIC" DILATOR, THE PROXIMAL END SNAPPED AND THE INTRODUCER HAS TO BE CHANGED. NO HARM TO THE PATIENT. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17019198 ↗

Other Introducer, catheter devices

All Introducer, catheter devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.