ARROW IPN924161Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902208658), received between Jan 11, 2024 and Jul 8, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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-2367-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED "WHEN LINE WAS REMOVED AFTER COMPLETING THERAPY THE NURSE SAW THAT A HOLE IN THE LINE." 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 22437506 ↗
• MalfunctionJan 11, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT: TRIPLE LUMEN PLACED IN PATIENT. LATER, THE PATIENT WENT TO CT AND WHILE THERE THE TECH AND PATIENT BOTH HEARD A POP. PATIENT WENT BACK TO ICU AND THEY HAD THE TEAM CHECK THE LINE. FLUSH BUT NO BLOOD RETURN. PUT ULTRASOUND ON IT AND THEY SAW AN INFILTRATION IN THE ARM. THEY REMOVED THE LINE AND THEY SAID IT LOOKS LIKE WHEN A PIPE FREEZES AND CRACKS. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18493117 ↗