ARROW IPN036452Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 50801902117019), received between Sep 1, 2022 and May 2, 2025 — classified as 3 malfunctions.

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

2 FDA recall records name this device's identifier, 2 still open.

10 other recalls cover devices cleared under the same FDA submission (K011761); 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.

Recalls naming this device

1. Apr 21, 2026Open, Classified

   Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

   Z-2369-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Apr 21, 2026Open, Classified

   Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

   Z-2376-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED "AFTER PHYSICIAN PULLED THE SWAN CATHETER OUR OF THE PSI, THE VALVE CAME OUT OF THE PSI CATHETER AND BLOOD STARTED GUSHING OUT. CLINICAL TEAM PULLED THE ENTIRE PSI CATHETER OUT OF THE PATIENT TO STOP BLEEDING. THEY THEN PLACED A CENTRAL LINE FOR ACCESS ON THE PATIENT'S OTHER SIDE." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21950251 ↗
• MalfunctionSep 1, 2022Unraveled Material; Unraveled Material

  CUSTOMER REPORTED ISSUE WITH GUIDEWIRE "FRAYING OR SHREDDING" DURING REMOVAL. IT WAS REPORTED THE DOCTOR WAS ABLE TO CLAMP THE WIRE AND REMOVE IT BEFORE IT BROKE. NO PATIENT HARM WAS REPORTED. IT WAS REPORTED THERE WERE TWO DEVICES WITH THIS ISSUE, ONE RIGHT AFTER THE FIRST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15342533 ↗
• MalfunctionSep 1, 2022Unraveled Material; Unraveled Material

  CUSTOMER REPORTED ISSUE WITH GUIDEWIRE "FRAYING OR SHREDDING" DURING REMOVAL. IT WAS REPORTED THE DOCTOR WAS ABLE TO CLAMP THE WIRE AND REMOVE IT BEFORE IT BROKE. NO PATIENT HARM WAS REPORTED. IT WAS REPORTED THERE WERE TWO DEVICES WITH THIS ISSUE, ONE RIGHT AFTER THE FIRST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15342525 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011761. 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-2555-2019 · Aug 6, 2019 · Terminated
  8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: The MACTM Two-Lumen Central Venous Access Device wit
• Z-1983-2018 · Apr 11, 2018 · Terminated
  MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for use with 7.5 - 8 Fr. Catheters; Product
• Z-1324-2018 · Dec 22, 2017 · Terminated
  (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Centra
• Z-1000-2018 · Nov 27, 2017 · Terminated
  ARROWg+ard Blue MAC" Two-Lumen Central Venous Access Kit Product Usage: The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of disease
• Z-1002-2018 · Nov 27, 2017 · Terminated
  ARROWg+ard Blue Product Usage: The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous
• Z-2333-2017 · May 9, 2017 · Terminated
  1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 4) ARROWg+ard Blue PSI Kit The MACT
• Z-2825-2015 · Aug 27, 2015 · Terminated
  Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
• Z-0066-2015 · Aug 6, 2014 · Terminated
  Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
• Z-0783-2010 · Nov 24, 2009 · Terminated
  MAC (TM) Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with