ARROW IPN036826Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10801902117516), received between Dec 14, 2018 and May 26, 2026 — classified as 1 injury, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Fluid/Blood Leak; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING INSERTION OF A RIGHT VENTRICULAR PACING GUIDEWIRE (RVP), THE DEVICE EXHIBITED LEAKAGE AND WAS DEEMED UNUSABLE. NO VISIBLE DAMAGE TO THE DEVICE WAS OBSERVED (E.G., NO TEARS, CUTS, OR HOLES). THE DISTRIBUTOR REPORTED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT. GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE DEVICE ISSUE AND THE PATIENT'S CLINICAL OUTCOME; HOWEVER, NO RESPONSE OR FURTHER DETAILS WERE RECEIVED FROM THE REPORTING FACILITY. NO ADVERSE CLINICAL OUTCOMES WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25279920 ↗
• InjuryFeb 21, 2024Material Separation; Material Separation

  THE REPORT STATES: "A SMALL PIECE OF THE CVC GUIDEWIRE FRACTURED DURING CODE BLUE FEMORAL PLACEMENT. THE CV SURGEON WAS ABLE TO SNARE THE WIRE WITH A FORCEP IN THE SICU".

  Patient problems: Insufficient Information

  MAUDE report 18746145 ↗
• MalfunctionJun 27, 2023Contamination

  HAIR WAS FOUND WOUND AROUND THE CATH-GARD CATHETER CONTAMINATION SHIELD: 80CM WITH TWISTLOCK ADAPTER THAT WAS IN THE ARRROWG+ARD BLUE PSIFOR USE WITH 7.5-8 FR. CATHETERS INTRODUCER KIT WHEN IT WAS OPENED TO START SWAN PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17208423 ↗
• MalfunctionJun 20, 2023Fitting Problem; Fitting Problem

  CUSTOMER REPORTED "THIS PRODUCT DOES NOT ADVANCE EASILY INTO THE IJ WITHOUT HAVING THE DILATOR SEPARATE FROM THE INTRODUCER". THE USER HAS TO BEND THE SPRING WIRE GUIDE AROUND THE DILATOR TO KEEP BOTH THE WIRE AND DILATOR IN PLACE. IT WAS REPORTED THE DILATOR WILL DISLODGE FROM ITS PLACE IN THE PATIENT AND A LARGER SKIN INCISION NEEDS TO BE MADE. SURGICEL IS USED TO CONTROL BLEEDING AT THE INSERTION SITE. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17164858 ↗
• MalfunctionMar 22, 2021Obstruction of Flow; Obstruction of Flow

  CUSTOMER REPORTED "BLOOD BACKING UP INTO THE SIDE PORT OF THE INTRODUCER WITH IV FLUIDS INFUSING INTO THAT PORT. THE MAIN LINE WITH THE HEMOSTAIS VALVE HAD A SWAN-GANZ CATHETER IN PLACE AT THAT TIME. ONCE THE SWAN-GANZ WAS PULLED OUT AND THAT PORT CAPPED WITH OBTURATOR, THE NURSE ATTEMPTED TO WITHDRAW BLOOD FROM SIDE PORT PRIOR TO FLUSHING THE LINE AND PULLED A 3 INCH LONG BLOOD CLOT OUT OF THE LINE."

  Patient problems: Insufficient Information

  MAUDE report 11541620 ↗
• MalfunctionDec 14, 2018Device Contamination with Chemical or Other Material

  STERILITY ISSUE: THIS MORNING IN CARDIAC SURGERY ANESTHESIOLOGIST FOUND A CORDIS WITH CLEARLY FOREIGN MATERIAL AT THE ENTRY VALVE. (WAS OPENED FOR USE ON THE PATIENT). DID NOT GO INTO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8163710 ↗

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