ARROW IPN030216Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10801902100280), received between Aug 5, 2021 and Dec 3, 2025 — classified as 1 injury, 8 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K991431); 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT "DURING INSERTION, THE GUIDE SPLIT IN TWO. WHEN IT WAS REMOVED AFTER INSERTING THE CATHETER, THE GUIDE BROKE. THE CATHETER HAD TO BE REMOVED. ANOTHER DEVICE WAS USED". NO REPORT OF PATIENT HARM OR INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23708163 ↗
• MalfunctionJun 13, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED " A DIALYSIS CATHETER WAS INSTALLED IN THE ICU AFTER INSERTING AND REMOVING THE GUIDEWIRE. THIS CATHETER HAS MULTIPLE KINKS. A NEW CATHETER ASSEMBLY MUST BE OPENED TO USE THE NEW GUIDEWIRE." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202403 ↗
• MalfunctionJun 6, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE INTRODUCER NEEDLE HAS BENT DURING PUNCTURE WHICH COULD CREATE DEVIATION AND IS NOT SAFE." THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO DELAY TO THERAPY AND NO PATIETN 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 19476454 ↗
• MalfunctionApr 2, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT: "THE CATHETER DID NOT WORK, THE FEELING WAS THAT THE INTERNAL LIGHTS WERE IN COMMUNICATION, THERE WAS RECIRCULATION. THEY CHANGED THE MACHINE AND THE ISSUE CONTINUED" ANOTHER CATHETER WAS USED SUCCESSFULLY. ADDITIONAL INFORMATION: THE ISSUE WAS IDENTIFIED DURING USE. THERE WAS NO PATIENT HARM, THEY WERE REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19018017 ↗
• MalfunctionApr 2, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT: "THE CATHETER DID NOT WORK, THE FEELING WAS THAT THE INTERNAL LIGHTS WERE IN COMMUNICATION, THERE WAS RECIRCULATION. THEY CHANGED THE MACHINE AND THE ISSUE CONTINUED" ANOTHER CATHETER WAS USED SUCCESSFULLY. ADDITIONAL INFORMATION: THE ISSUE WAS IDENTIFIED DURING USE. THERE WAS NO PATIENT HARM, THEY WERE REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19017979 ↗
• MalfunctionApr 2, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT: "THE CATHETER DID NOT WORK, THE FEELING WAS THAT THE INTERNAL LIGHTS WERE IN COMMUNICATION, THERE WAS RECIRCULATION. THEY CHANGED THE MACHINE AND THE ISSUE CONTINUED" THE ISSUE WAS IDENTIFIED PRIOR TO USE ON A PATIENT DURING INSPECTION/FUNCTIONAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19017952 ↗
• MalfunctionFeb 20, 2024Material Twisted/Bent; Material Twisted/Bent

  "IT WAS REPORTED "WHEN THE DILATATOR, THE DISTAL PART OF IT IS BENT" THE DOCTOR USED A DILATOR FROM ANOTHER CVC KIT WHICH SUCCESSFULLY DILATED THE VEIN" ADDITIONAL INFORMATION REPORTS MALFUNCTION REQUIRED NURSING MANAGEMENT AND ANALGESIC TREATMENT. THE PATIENT'S CURRENT CONDITION IS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18740825 ↗
• MalfunctionFeb 15, 2024Material Twisted/Bent; Material Twisted/Bent

  "IT WAS REPORTED "WHEN THE DILATATOR, THE DISTAL PART OF IT IS BENT" THE DOCTOR USED A DILATOR FROM ANOTHER CVC KIT WHICH SUCCESSFULLY DILATED THE VEIN".ADDITIONAL INFORMATION REPORTS MALFUNCTION REQUIRED NURSING MANAGEMENT AND ANALGESIC TREATMENT. THE PATIENT'S CURRENT CONDITION IS "FINE". ASSOCIATED MDR NUMBER: 9680794-2024-00193, 9680794-2024-00131, 3006425876-2024-00219.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710749 ↗
• InjuryAug 5, 2021Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTS FINDING A WOUND IN THE ATRIUM OF THE PATIENT'S HEART BESIDE THE POSITION OF THE CATHETER. CATHETER INSERTED (B)(6) 2021 IN RIGHT JUGULAR FOR PLASMA EXCHANGES. PATIENT EXPERIENCED HEMOPERICARDIUM, AND EMERGENCY DRAINAGE AND SURGICAL MANAGEMENT FOR SUTURING WOUND WERE PERFORMED. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE FOR POSTOPERATIVE FOLLOW UP. IT WAS REPORTED AN X-RAY WAS TAKEN FOLLOWING CATHETER PLACEMENT AND ALTHOUGH IT WAS DIFFICULT TO VISUALIZE THE TIP OF THE CATHETER (DUE TO POOR QUALITY OF X-RAY), IT SEEMED TO BE IN FRONT OF THE RIGHT ATRIUM. SURGICAL REPAIR OF RIGHT ATRIUM WAS PERFORMED 48 HOURS AFTER PLACEMENT OF CATHETER. CUSTOMER REPORTED THE LENGTH OF THE CATHETER TO THE GUARD WAS LONGER THAN THE LENGTH OF THE CATHETER ANNOUNCED BY THE MANUFACTURER, NOTING 20 CM WERE INDICATED BY A BLACK MARKING BUT THE TUBING ALLOWS THE INTRODUCTION OF 23CM. AT THE TIME OF THIS REPORT, THE PATIENT WAS OUT OF INTENSIVE CARE AND THE CLINICAL TEAM DECIDED NOT TO RESUME PLASMA EXCHANGES. IT WAS REPORTED THE DEVICE WAS REMOVED IN INTENSIVE CARE.

  Patient problems: Pericardial Effusion

  MAUDE report 12283840 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K991431. One submission often covers many models, so check the product and lot details in each record.

• Z-0639-04 · Feb 18, 2004 · Terminated
  Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved Catheter for high Volume Ifusions