ARROW IPN032946Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801902096128), received between Aug 20, 2021 and Nov 25, 2024 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "ON (B)(6) 2024, THE DOCTOR FOUND THE EXTENSION LINE LEAK DURING USE ON THE PATIENT. THEY CHANGED A NEW ONE. NO HARM FOR THE PATIENT." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20772330 ↗
• MalfunctionAug 20, 2021Crack; Crack

  IT WAS REPORTED THE LUER HUB WAS FOUND CRACKED DURING HEMODIALYSIS. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12350513 ↗

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.