ARROW IPN036349Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902141122), received between Mar 10, 2020 and Mar 10, 2020 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

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

• InjuryMar 10, 2020Material Protrusion/Extrusion

  AN ARROWG+ARD BLUE MAC CATHETER WAS INADVERTENTLY PLACED INTO THE RIGHT CAROTID ARTERY DURING ATTEMPTED INTERNAL JUGULAR VEIN CANNULATION. THE RESULTING ARTERIAL INJURY REQUIRED SURGICAL REPAIR, AND THE PT SUBSEQUENTLY SUFFERED AN EMBOLIC STROKE. OUR SUBSEQUENT STIMULATION OF THE DEVICE INSERTION DEMONSTRATED THAT THE DILATOR CAN PUNCTURE THE POSTERIOR VESSEL WALL, POTENTIALLY DAMAGING ADJACENT STRUCTURES, WHEN THE GUIDEWIRE IS NOT INSERTED TO SUFFICIENT DEPTH. UNDER THESE CONDITIONS, THE SHARP TIP OF THE DILATOR IS NOT PROTECTED BY PROTRUDING GUIDEWIRE AND CAN DIRECTLY CONTACT AND PENETRATE THE POSTERIOR VESSEL WALL. WITHOUT SUFFICIENT WIRE TO GUIDE IT, THE DILATOR FOLLOWS A STRAIGHT TRAJECTORY FROM THE SKIN SURFACE INCREASING THE LIKELIHOOD THAT IT WILL PENETRATE THE POSTERIOR VESSEL WALL, RATHER THAN FOLLOWING THE VESSEL LUMEN. THE MFR DOES NOT PROVIDE INSTRUCTIONS ON APPROPRIATE GUIDEWIRE INSERTION DEPTH, AND THE GUIDEWIRE IS NOT MARKED TO INDICATE APPROPRIATE INSERTION DEPTH. THE 45CM GUIDEWIRE PROVIDED IN THE KIT MAY CONTRIBUTE TO THE RISK OF THIS COMPLICATION; A LONGER (60CM) GUIDEWIRE IS PROVIDED IN A TRIPLE-LUMEN CATHETER BY THE SAME MFR. THE 45CM GUIDEWIRE DOES NOT PROVID

  Patient problems: Injury; Stroke/CVA

  MAUDE report 9818334 ↗
• InjuryMar 10, 2020Inadequate Instructions for Healthcare Professional; Inadequacy of Device Shape and/or Size

  DURING AN ATTEMPTED FEMORAL VEIN CANNULATION WITH AN ARROWG+ARD BLUE MAC CATHETER, THE FEMORAL ARTERY WAS DAMAGED. THE PT'S LEG REQUIRED SURGICAL AMPUTATION AS A COMPLICATION OF THE VASCULAR INJURY. OUR SUBSEQUENT STIMULATION OF THE DEVICE INSERTION DEMONSTRATED THAT THE DILATOR CAN PUNCTURE THE POSTERIOR VESSEL WALL, POTENTIALLY DAMAGING ADJACENT STRUCTURES, WHEN THE GUIDEWIRE IS NOT INSERTED TO SUFFICIENT DEPTH. UNDER THESE CONDITIONS, THE SHARP TIP OF THE DILATOR IS NOT PROTECTED BY PROTRUDING GUIDEWIRE AND CAN DIRECTLY CONTACT AND PENETRATE THE POSTERIOR VESSEL WALL. WITHOUT SUFFICIENT WIRE TO GUIDE IT, THE DILATOR FOLLOWS A STRAIGHT TRAJECTORY FROM THE SKIN SURFACE INCREASING THE LIKELIHOOD THAT IT WILL PENETRATE THE POSTERIOR VESSEL WALL, RATHER THAN FOLLOWING THE VESSEL LUMEN. THE MFR DOES NOT PROVIDE INSTRUCTIONS ON APPROPRIATE GUIDEWIRE INSERTION DEPTH, AND THE GUIDEWIRE IS NOT MARKED TO INDICATE APPROPRIATE INSERTION DEPTH. THE 45CM GUIDEWIRE PROVIDED IN THE KIT MAY CONTRIBUTE TO THE RISK OF THIS COMPLICATION; A LONGER (60CM) GUIDEWIRE IS PROVIDED IN A TRIPLE-LUMEN CATHETER BY THE SAME MFR. THE 45CM GUIDEWIRE DOES NOT PROVIDE SUFFICIENT LENGTH WITHIN THE TARGET VESSEL IF

  Patient problems: Injury; No Code Available

  MAUDE report 9818302 ↗
• DeathMar 10, 2020Malposition of Device

  AN ARROWG+ARD BLUE MAC CATHETER WAS INADVERTENTLY PLACED INTO THE JUNCTION OF THE RIGHT CAROTID ARTERY AND SUBCLAVIAN ARTERY DURING ATTEMPTED INTERNAL JUGULAR VEIN CANNULATION. THE RESULTING ARTERIAL INJURY REQUIRED SURGICAL REPAIR AND THE PT SUBSEQUENTLY SUFFERED AN EMBOLIC STROKE, FOLLOWED BY DEATH. OUR SUBSEQUENT SIMULATION OF THE DEVICE INSERTION DEMONSTRATED THAT THE DILATOR CAN PUNCTURE THE POSTERIOR VESSEL WALL, POTENTIALLY DAMAGING ADJACENT STRUCTURES, WHEN THE GUIDEWIRE IS NOT INSERTED TO SUFFICIENT DEPTH. UNDER THESE CONDITIONS, THE SHARP TIP OF THE DILATOR IS NOT PROTECTED BY PROTRUDING GUIDEWIRE AND CAN DIRECTLY CONTACT AND PENETRATE THE POSTERIOR VESSEL WALL. WITHOUT SUFFICIENT WIRE TO GUIDE IT, THE DILATOR FOLLOWS A STRAIGHT TRAJECTORY FROM THE SKIN SURFACE, INCREASING THE LIKELIHOOD THAT IT WILL PENETRATE THE POSTERIOR VESSEL WALL, RATHER THAN FOLLOWING THE VESSEL LUMEN. THE MFR DOES NOT PROVIDE INSTRUCTIONS ON APPROPRIATE GUIDEWIRE INSERTION DEPTH, THE 45CM GUIDEWIRE PROVIDED IN THE KIT MAY CONTRIBUTE TO THE RISK OF THIS COMPLICATION, A LONGER (60CM) GUIDEWIRE IS PROVIDED IN A TRIPLE-LUME CATHETER BY THE SAME MFR. THE 45CM GUIDEWIRE DOES NOT PROVIDE SUFFICIENT LENGT

  Patient problems: Death; Injury; Stroke/CVA

  MAUDE report 9817849 ↗

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-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-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-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