ARROW IPN033232Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801902096807), received between May 1, 2024 and May 1, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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 1, 2024Crack; Crack

  IT WAS REPORTED "THE LUER HUB/FITTING WAS CRACK DURING USED ON THE PATIENT." THE USER SWITCHED TO A NEW SET. NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219837 ↗

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.