ARROW IPN037697 (REF CDC-41541-MPK1A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902130157), received between Apr 13, 2023 and Apr 13, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K161313); 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.

• MalfunctionApr 13, 2023Material Separation; Material Separation

  THE COMPLAINT IS REPORTED AS: THE VASCULAR ACCESS TEAM WAS CALLED TO REMOVE A SINGLE LUMEN MIDLINE. THE PATIENT, WHO WAS A VERY SMALL ELDERLY LADY, HAD PULLED THE PIGTAIL OF HER CATHETER. IT SNAPPED, LEAVING THE HUB WITHIN THE STATLOCK AND THE CATHETER INDWELLING. NO PATIENT HARM WAS REPORTED. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16734641 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161313. One submission often covers many models, so check the product and lot details in each record.

• Z-0102-2023 · Sep 14, 2022 · Terminated
  ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intrave
• Z-1818-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS