ARROW IPN030360Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801902102911), received between May 1, 2025 and Aug 18, 2025 — classified as 3 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 (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.

• MalfunctionAug 18, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED "WHEN USING THE CATHETER GUIDE, WHEN ADVANCING THROUGH THE NEEDLE, THE EQUIPMENT STAYS "STUCK", NOT ADVANCING IN ANY DIRECTION AND CANNOT BE REMOVED FROM THE NEEDLE, BECOMING TRAPPED IN THE MIDDLE OF THE NEEDLE (IT CANNOT EXIT FROM IT). WHEN REMOVING IN BLOCK, THE GUIDE CAN FINALLY BE REMOVED FROM THE NEEDLE AND IS FOUND "UNHOOKED". THE GUIDEWIRE WAS REPLACED AND SUCCESSFULLY USED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "PROGRESSING WELL CLINICALLY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22826907 ↗
• MalfunctionMay 2, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "DURING THE SURGICAL PROCEDURE, DIFFICULTIES AROSE WHILE ATTEMPTING TO INSERT THE MAC INTRODUCER CATHETER INTO THE PATIENT. DESPITE MULTIPLE ATTEMPTS UNDER ULTRASOUND GUIDANCE, THE ANESTHESIOLOGIST NOTED THAT THE TIP OF THE DEVICE WAS BENT AND SHOWED SIGNS OF WEAR, PREVENTING PROPER PLACEMENT. A REPLACEMENT INTRODUCER WAS OPENED; HOWEVER, UPON INSPECTION, IT EXHIBITED THE SAME DEFECT (DEFORMED AND DETERIORATED TIP). GIVEN THIS ISSUE, THE HEAD OF PHARMACY WAS IMMEDIATELY NOTIFIED, AND A THIRD DEVICE WAS REQUESTED. FORTUNATELY, THE FINAL UNIT WAS FOUND TO BE IN OPTIMAL CONDITION, ALLOWING THE PROCEDURE TO BE SUCCESSFULLY COMPLETED." 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 21950139 ↗
• MalfunctionMay 1, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE SERVICE REPORTS THAT WHEN TRANSFERRING THE MEDICAL DEVICE TO THE STERILE TABLE, THE SPECIALIST CHECKS THE GUIDE OF THE MAC SHIRT KIT AND FINDS THAT IT IS BENT, SO SHE DECIDES TO REQUEST A SECOND MAC SHIRT." 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 21942046 ↗

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