ARROW IPN036823Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30801902122255), received between Apr 8, 2026 and Apr 8, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

9 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.

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-2385-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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.

• MalfunctionApr 8, 2026Unraveled Material; Difficult to Advance

  IT WAS REPORTED THAT: "SPRING WIRE "UNRAVELING" DURING INSERTION. SPRING WIRE REMOVED FROM ADVANCER AND INSERTED STRAIGHT END, RAULERSON NOT USED, WIRE REPORTEDLY PULLED BACK THROUGH NEEDLE WHEN IT COULD NOT BE ADVANCED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24815645 ↗

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-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