ARROW IPN929678Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902220339), received between Apr 21, 2026 and Apr 22, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

1 FDA recall record name this device's identifier, 1 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 ↗

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.

• MalfunctionApr 22, 2026Fluid/Blood Leak

  IT WAS REPORTED, "THE CUSTOMER REPORTED THAT WHEN FLUSHING THE PROXIMAL EXTENSION LUMEN THERE WAS LEAKING FROM THE JUNCTURE HUB/MAIN CATHETER. THIS WOULD OCCUR AFTER THE PATIENT LEFT THE OR AND ARRIVED IN THE CVICU. THERE IS NO REPORTED PATIENT HARM, INJURY OR HEALTH CONSEQUENCES. THE FELLOW IN THE CVICU REMOVED THE MAC CATHETER BECAUSE THE THERAPY WAS CONCLUDED. THE PATIENT'S CURRENT CONDITION AFTER THE MAC CATHETER WAS REMOVED WAS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955187 ↗
• MalfunctionApr 22, 2026Fluid/Blood Leak

  IT WAS REPORTED, "LEAKING AT THE INSERTION SITE ONLY WHEN FLUSHING OR INFUSING THE PROXIMAL LUMEN (WHITE LUMEN). FLUSHES FREE AND CLEAR, NO RESISTANCE AND ASPIRATION. NO SIMILARITIES WITH STAFF OR INSERTERS. NO INCREASE IN VOLUME WHILE LEAKING AT THE INSERTION SITE.". ADDITIONAL INFORMATION RECEIVED ON 02APR2026: "THE CATHETER WAS INDWELLING FOR APPROXIMATELY 3-5 DAYS. THERE WAS LEAKING FROM THE INSERTION SITE. THE MULTI ACCESS CATHETER (MAC) WAS REMOVED DUE TO EVENT.". THERE WAS NO REPORT OF ANY PATIENT INJURY OR CONSEQUENCE. THE PATIENT'S CURRENT CONDITION WAS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954040 ↗
• MalfunctionApr 21, 2026Fluid/Blood Leak

  IT WAS REPORTED, "LEAKING AT THE INSERTION SITE ONLY WHEN FLUSHING OR INFUSING THE PROXIMAL LUMEN (WHITE LUMEN). FLUSHES FREE AND CLEAR, NO RESISTANCE AND ASPIRATION. NO SIMILARITIES WITH STAFF OR INSERTERS. NO INCREASE IN VOLUME WHILE LEAKING AT THE INSERTION SITE.". ADDITIONAL INFORMATION RECEIVED ON 02APR2026: "THE CATHETER WAS INDWELLING FOR APPROXIMATELY 3-4 DAYS. THERE WAS WEEPING FROM THE LEAKING INSERTION SITE. THE MULTI ACCESS CATHETER (MAC) WAS REMOVED AND NOT REPLACED DUE TO THERAPY HAS BEEN COMPLETED.". THERE WAS NO REPORT OF ANY PATIENT INJURY OR CONSEQUENCE. THE PATIENT'S CURRENT CONDITION WAS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945982 ↗

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