ARROW IPN037085Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30801902121920), received between Aug 13, 2024 and Aug 13, 2024 — classified as 1 malfunction.

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

64 other recalls cover devices cleared under the same FDA submission (K002507); 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.

• MalfunctionAug 13, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED "INSERTION WENT SMOOTHLY. ULTRASOUND SHOWED CATHETER WAS IN CORRECT POSITION IN LOWER RIGHT ATRIUM. WENT TO PULL BACK WIRE AND ABOUT 2/3 OF THE WAY THE CATHETER SNAGGED AND IT GOT STUCK. THEY PULLED BACK THE WHOLE UNIT TOGETHER AND SAW THE END OF THE WIRE AT THE J LOOP WAS CURLED AND HAD UNRAVELED AT THE END. WIRE WAS INTACT THOUGH, NO PIECES FELL OFF." THERE WAS 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 19975733 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002507. 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-0352-2023 · Oct 27, 2022 · Terminated
  Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-
• Z-0351-2023 · Oct 27, 2022 · Terminated
  Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
• Z-1323-2018 · Dec 22, 2017 · Terminated
  (1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow MAC" Two- Lumen Central Venous Access Kit, Product Number:
• Z-2335-2017 · May 9, 2017 · Terminated
  Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central ci
• Z-2282-2017 · Mar 20, 2017 · Terminated
  Arrow VPS Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System)
• Z-2297-2017 · Mar 20, 2017 · Terminated
  Radial Artery Catheterization Kit with Sharps Safety Features The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vess
• Z-2261-2017 · Mar 20, 2017 · Terminated
  Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostatis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5-8 Fr
• Z-2308-2017 · Mar 20, 2017 · Terminated
  ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access
• Z-2300-2017 · Mar 20, 2017 · Terminated
  Arterial Catheterization Kit The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
• Z-2288-2017 · Mar 20, 2017 · Terminated
  Arrow(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduct
• Z-2304-2017 · Mar 20, 2017 · 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 Fr
• Z-2278-2017 · Mar 20, 2017 · Terminated
  AGB+ Pressure Injectable Multi-Lumen CVC Kit intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins intended to permit venou
• Z-2302-2017 · Mar 20, 2017 · Terminated
  Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to
• Z-2256-2017 · Mar 20, 2017 · Terminated
  Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intra

…and 49 more.