ARROW IPN918405Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902179330), received between May 2, 2025 and May 2, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

10 other recalls cover devices cleared under the same FDA submission (K940079); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionMay 2, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE DOCTORS DISLIKE THIS KIT BECAUSE THE PSI MATERIAL IS VERY THIN AND IT SPLITS AND IT BENDS. ON THIS OCCASION THEY MADE A SKIN NICK AND THE CATHETER KEPT BENDING. THEY WENT THROUGH 2 MORE BEFORE THEY WERE SUCCESSFUL." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00425, 9680794-2025-00361.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21951353 ↗
• MalfunctionMay 2, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE DOCTORS DISLIKE THIS KIT BECAUSE THE PSI MATERIAL IS VERY THIN AND IT SPLITS AND IT BENDS. ON THIS OCCASION THEY MADE A SKIN NICK AND THE CATHETER KEPT BENDING. THEY WENT THROUGH 2 MORE BEFORE THEY WERE SUCCESSFUL." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00425, 9680794-2025-00361, AND 9680794-2025-00357.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21951255 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K940079. One submission often covers many models, so check the product and lot details in each record.

• Z-2385-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1; PSI KIT: 9 FR X 10 CM/ASK-09903-KH;
• Z-1975-2018 · Apr 11, 2018 · Terminated
  Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters ; Product Codes: ASK-0990
• Z-1986-2018 · Apr 11, 2018 · Terminated
  Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8
• Z-2017-2018 · Apr 11, 2018 · Terminated
  Percutaneous Sheath Introducer Kit with ARROWgard Blue Sheath and Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheters; Product Codes: MSO-29802-AHS and MSO-29903
• Z-2018-2018 · Apr 11, 2018 · Terminated
  ARROWgard Blue PLUS Multi-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: MSO-45703-AHS
• Z-1334-2018 · Dec 22, 2017 · Terminated
  Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with 7.5 - 8 Fr. Catheters PN: ASK-29903-UCD
• Z-1160-2018 · Nov 14, 2017 · Terminated
  Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr
• Z-0784-2010 · Nov 24, 2009 · Terminated
  Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8
• Z-1492-2009 · Feb 11, 2009 · Terminated
  Arrow ARROWg+ard Super Arrow-Flex Percutaneous Sheath Introducers
• Z-1035-03 · Jul 8, 2003 · Terminated
  9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue Antimicrobial Surface Sheath