ARROW IPN000006Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801902066626), received between Jan 2, 2019 and Jan 2, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

• MalfunctionJan 2, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: "DURING A PROCEDURE, AFTER THE INTERVENTION AND DURING REMOVAL OF THE INTRODUCER, THE NURSE OBSERVED A SMALL QUANTITY OF BLOOD (LEAK) AT THE LEVEL OF THE JUNCTION BETWEEN THE BASE AND THE BODY OF THE INTRODUCER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8207747 ↗

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