ARROW IPN001130Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902124446), received between Oct 5, 2020 and Oct 5, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

1 other recall cover devices cleared under the same FDA submission (K112554); they may or may not involve this specific model.

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.

• MalfunctionOct 5, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE INTRODUCER OF THE CATHETER KIT WAS CAUSING DAMAGE TO THE GUIDE WIRE AND DIFFICULTY IN TAKING OUT OF THE RADIAL ARTERY. AS A RESULT, THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH A NEW KIT AND INSERTING THROUGH THE FEMORAL ARTERY. THERE WAS NO REPORT OF PATIENT COMPLICATIONS.

  Patient problems: Needle Stick/Puncture; No Consequences Or Impact To Patient

  MAUDE report 10631079 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112554. One submission often covers many models, so check the product and lot details in each record.

• Z-0468-2014 · Oct 9, 2013 · Terminated
  Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and thera