ARROW IPN921994Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902205473), received between Nov 18, 2025 and Sep 8, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668175 ↗
• MalfunctionSep 3, 2026Deformation Due to Compressive Stress; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50577059 ↗
• MalfunctionNov 18, 2025Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT "AFTER INSERTION OF THE SURFLOW NEEDLE WITH A HEMOSTASIS VALVE THE USER ATTEMPTED TO INSERT THE SWG. HOWEVER, THE SWG COULD NOT BE ADVANCED AND GOT KINKED. THEREFORE, A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT OCCURRED." 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 23586273 ↗
• MalfunctionNov 18, 2025Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT "AFTER INSERTION OF THE SURFLOW NEEDLE WITH A HEMOSTASIS VALVE THE USER ATTEMPTED TO INSERT THE SWG. HOWEVER, THE SWG COULD NOT BE ADVANCED AND GOT KINKED. THEREFORE, A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT OCCURRED." 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 23586252 ↗

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