ARROW IPN036821Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 30801902122248), received between Oct 1, 2021 and Nov 20, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (4 reports).

2 FDA recall records name this device's identifier, 2 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 ↗

2. 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-2377-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT: "DR. WAS PLACING THE GUIDE WIRE AND IT CAUGHT ON SOMETHING. WHEN IT WAS REMOVED IT WAS FRAYED. HAD TO PULL THE WHOLE THING OUT AND OPEN NEW KIT. THERE WAS NO REPORTED PATIENT HARM OR INJURY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604166 ↗
• MalfunctionOct 8, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED "THE GUIDEWIRE IN THE KIT UNCOILED WHILE WITHDRAWING FROM THE PATIENT." 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 20399637 ↗
• MalfunctionOct 8, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED "THE GUIDEWIRE IN THE KIT UNCOILED WHILE WITHDRAWING FROM THE PATIENT." 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 20399052 ↗
• MalfunctionOct 1, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT: "THE INTERNAL WIRE HAD COME OUT OF THE COILED EXTERNAL WIRE WITH COIL STILL IN TACT. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.".

  Patient problems: Insufficient Information

  MAUDE report 20342141 ↗
• InjuryOct 12, 2021Malposition of Device; Malposition of Device

  PHYSICIAN USED ULTRASOUND TO IDENTIFY THE RIGHT INTERNAL JUGULAR VEIN. HE GOT FLASHBACK WITH THE INTRODUCER. PUT THE GUIDEWIRE DOWN. ADVANCED A 2 LUMEN PSI IN THE USUAL FASHION. IT WAS DISCOVERED LATER WHEN THE PATIENT HAD A THORACOTOMY, THAT THE SHEATH WENT THROUGH THE VESSEL. IT WAS REPORTED THE PATIENT HAD A GUNSHOT WOUND TO THE RIGHT UPPER QUADRANT. A CHEST TUBE WAS PLACED IN THE EMERGENCY ROOM. AFTER THE SHEATH WAS PLACED THE PATIENT EXPERIENCED A HEMOTHORAX WITH SIGNIFICANT PNEUMOTHORAX, ESTIMATED 3 TO 5 LITERS OF BLOOD. A THORACOTOMY WAS PERFORMED FOR THE INCREASED OUTPUT FROM THE CHEST TUBE. ON EXPLORATION OF THE GUNSHOT WOUND THE SURGEON SAW THE SHEATH IN THE THORAX. IT WAS REPORTED THE INCREASED OUTPUT FROM THE CHEST TUBE WAS RELATED TO THE INJURY CAUSED BY THE SHEATH. THE VESSEL WAS REPAIRED AT THE SAME TIME AS THE GUNSHOT WOUND INJURY. THE PATIENT SURVIVED AND WAS DISCHARGED 2-3 DAYS LATER.

  Patient problems: Perforation of Vessels

  MAUDE report 12618529 ↗
• MalfunctionOct 6, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE COMPLAINT IS REPORTED AS: TIP OF DILATORS BENT AND SEVERE KINKING WITH STAINLESS STEEL WIRE IN KIT. IT WAS REPORTED TWO DILATORS USED ON THE SAME PATIENT FOR A RIGHT SUBCLAVIAN VEIN CENTRAL LINE ATTEMPT. AFTER THE USER PULLED THE SECOND DILATOR OUT THAT WAS BENT, THE USER DECIDED TO ABANDON THE PCI AND INSTEAD PUT AN ARROW 18GA LONG CATHETER OVER IT 10.5CM IN LENGTH. NO PATIENT INJURY REPORTED. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12585260 ↗
• MalfunctionOct 6, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE COMPLAINT IS REPORTED AS: TIP OF DILATORS BENT AND SEVERE KINKING WITH STAINLESS STEEL WIRE IN KIT. IT WAS REPORTED TWO DILATORS USED ON THE SAME PATIENT FOR A RIGHT SUBCLAVIAN VEIN CENTRAL LINE ATTEMPT. AFTER THE USER PULLED THE SECOND DILATOR OUT THAT WAS BENT, THE USER DECIDED TO ABANDON THE PCI AND INSTEAD PUT AN ARROW 18GA LONG CATHETER OVER IT 10.5CM IN LENGTH. NO PATIENT INJURY REPORTED. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12585145 ↗
• MalfunctionOct 1, 2021Material Separation; Material Separation

  CUSTOMER REPORTED THE GUIDEWIRE WAS SHEERED DURING PROCEDURE AND WAS LODGED IN THE PATIENT. IT WAS REPORTED THE GUIDEWIRE BROKE OFF COMPLETELY AND 8 CM WAS LEFT INSIDE THE PATIENT. THE ICU NURSE NOTICED THE GUIDEWIRE POKING OUT OF THE PATIENT'S GROIN AND REMOVED IT AT THE BEDSIDE. NO MEDICAL INTERVENTION WAS REQUIRED. NO PATIENT HARM OR COMPLICATION REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12565027 ↗

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