ARROW IPN036444Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 30801902116834), received between Apr 16, 2021 and Nov 19, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Contamination” (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. 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-2385-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT: "WE HAD A MAC INTRODUCER THIS MORNING THAT THE SWAN/INTRODUCER SHEATH WAS VERY HARD TO CONNECT/DISCONNECT FROM THE HUB. THE SWAN WAS ALREADY FLOATED SO THE DOC DIDN'T WANT TO CHANGE OUT THE SHEATH. SWAN REMOVED FROM CENTRAL LINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593744 ↗
• MalfunctionMay 19, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "WHEN CATHETER WAS IN PLACE, CLINICIAN ATTEMPTED TO PULL BLOOD FROM THE BROWN PORT IT APPEARED TO BE PULLING AIR. NO BLOOD. CUSTOMER ATTEMPTED TO TEST THE CATHETER WITH STERILE SALINE AFTER IT WAS REMOVED AND IT SEEMED TO HAVE THE SAME ISSUE." ADDITIONAL INFORMATION RECEIVED STATES "THE BROWN PORT OF THE MAC WAS CAPPED OFF WITH A RED CAP AND NO LONGER USED ONCE FINDING THAT AIR WAS COMING INTO THE LUMEN." 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 22044280 ↗
• MalfunctionFeb 12, 2024Contamination; Contamination

  IT WAS REPORTED THAT "1 OF THE CATHETERS WAS FOUND TO BE DEFECTIVE FROM A KIT: TIP IS DISCOLORED AND DIRTY, ALSO LOOKS LIKE THERE IS A FOREIGN OBJECT IN ONE HOLE." A NEW KIT WAS USED TO FINISH THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. ASSOCIATED COMPLAINTS 9680794-2024-00164 AND 9680794-2024-00163.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684002 ↗
• MalfunctionNov 10, 2022Fitting Problem; Fitting Problem

  THE COMPLAINT IS REPORTED AS: MAC WAS INSERTED IN THE CVOR. A DAY OR TWO LATER THE SWAN WAS REMOVED IN THE ICU AND AN INDIVIDUAL AO-09000 (OBTURATOR) WAS USED TO TRY AND CAP OFF THE SHEATH. THE OBTURATOR CAP WOULD NOT FIT OVER THE PSI. THEREFORE; THEY WERE NOT ABLE TO PROPERLY SECURE THE PSI WITH OBTURATOR CAP. THE CLINICIAN WEDGED AS MUCH OF IT AS THEY COULD ONTO THE MAC. THEY ALSO FOUND THE EXTRA OBTURATOR CAP THAT CAME INSIDE THEIR MAC KIT. IT DID NOT FIT EITHER. THE MAC WAS DISCONTINUED LATER THAT DAY AND NO OTHER ADDITIONAL PROCEDURE WAS NEEDED. THE MAC HAD REACHED END OF THERAPY. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770712 ↗
• MalfunctionApr 16, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE COMPLAINT IS REPORTED AS: THE DOCTOR DIDN'T HAVE ANY ISSUE ADVANCING THE WIRE BUT WHEN HE TRIED TO ADVANCE THE INTRODUCER OVER THE WIRE IT FELT LIKE IT WAS GETTING HUNG UP AND CAUGHT. HE TRIED SEVERAL TIMES TO ADVANCE, BENDING THE CATHETER AND INTRODUCER IN THE PROCESS IN THE ATTEMPT. ANOTHER KIT WAS PULLED AND A NEW WIRE INTRODUCER AND CATHETER WAS ATTEMPTED TO BE PLACED WITH THE SAME RESULTS. A TRIPLE LUMEN KIT WAS PULLED AND CATHETER PLACED WITHOUT ANY PROBLEMS. NO PATIENT HARM OR INJURY REPORTED. THE PATIENT'S CONDITION WAS REPORTED AS CRITICAL, UNRELATED TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11679713 ↗

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-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