ARROW IPN920485Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20801902195238), received between May 4, 2026 and May 4, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K020430); 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.

• MalfunctionMay 4, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT "ON (B)(6) 2026, THE EXTENSION LINE WAS FOUND LEAKING DURING USED ON THE PATIENT." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE. NO MEDICAL INTERVENTION WAS NECESSARY, AND THE PROCEDURE WAS COMPLETED AFTER SWITCHING TO AN ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068743 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K020430. One submission often covers many models, so check the product and lot details in each record.

• Z-2804-2020 · Jul 6, 2020 · Terminated
  NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection assembly that has been damaged.
• Z-2802-2020 · Jul 6, 2020 · Terminated
  Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly that has been damaged.