ARROW IPN046639Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10801902013832), received between Oct 31, 2025 and Oct 31, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (12 reports).

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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT: "WE HAVE HAD SOME KITS ALL HAD BROKEN SODIUM CHLORIDE BOTTLES IN THE KITS. THE LIQUID WAS DRIED UP BUT THERE WERE SHARDS OF GLASS IN THE KIT. ALL WITH THE SAME LOT NUMBER". ASSOCIATED COMPLAINTS 9680794-2025-00881, 9680794-2025-00886, 9680794-2025-00888, 9680794-2025-00889, 9680794-2025-00890, 9680794-2025-00891, 9680794-2025-00892, 9680794-2025-00893, 9680794-2025-00884, 9680794-2025-00885 AND 9680794-2025-00880.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434999 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT: "WE HAVE HAD SOME KITS ALL HAD BROKEN SODIUM CHLORIDE BOTTLES IN THE KITS. THE LIQUID WAS DRIED UP BUT THERE WERE SHARDS OF GLASS IN THE KIT. ALL WITH THE SAME LOT NUMBER". ASSOCIATED COMPLAINTS 9680794-2025-00881, 9680794-2025-00886, 9680794-2025-00888, 9680794-2025-00889, 9680794-2025-00890, 9680794-2025-00891, 9680794-2025-00892, 9680794-2025-00893, 9680794-2025-00894, 9680794-2025-00884, 9680794-2025-00885 AND 9680794-2025-00880.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434996 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT: "WE HAVE HAD SOME KITS ALL HAD BROKEN SODIUM CHLORIDE BOTTLES IN THE KITS. THE LIQUID WAS DRIED UP BUT THERE WERE SHARDS OF GLASS IN THE KIT. ALL WITH THE SAME LOT NUMBER". ASSOCIATED COMPLAINTS 9680794-2025-00881, 9680794-2025-00886, 9680794-2025-00888, 9680794-2025-00889, 9680794-2025-00890, 9680794-2025-00891, 9680794-2025-00892,9680794-2025-00894, 9680794-2025-00884, 9680794-2025-00885 AND 9680794-2025-00880.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434953 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT: "WE HAVE HAD SOME KITS ALL HAD BROKEN SODIUM CHLORIDE BOTTLES IN THE KITS. THE LIQUID WAS DRIED UP BUT THERE WERE SHARDS OF GLASS IN THE KIT. ALL WITH THE SAME LOT NUMBER". ASSOCIATED COMPLAINTS 9680794-2025-00881, 9680794-2025-00886, 9680794-2025-00888, 9680794-2025-00889, 9680794-2025-00890, 9680794-2025-00891, 9680794-2025-00893, 9680794-2025-00894, 9680794-2025-00884, 9680794-2025-00885 AND 9680794-2025-00880.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434931 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT: "WE HAVE HAD SOME KITS ALL HAD BROKEN SODIUM CHLORIDE BOTTLES IN THE KITS. THE LIQUID WAS DRIED UP BUT THERE WERE SHARDS OF GLASS IN THE KIT. ALL WITH THE SAME LOT NUMBER". ASSOCIATED COMPLAINTS 9680794-2025-00881, 9680794-2025-00886, 9680794-2025-00888, 9680794-2025-00889, 9680794-2025-00890, 9680794-2025-00892, 9680794-2025-00893, 9680794-2025-00894, 9680794-2025-00884, 9680794-2025-00885 AND 9680794-2025-00880.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434913 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT: "WE HAVE HAD SOME KITS ALL HAD BROKEN SODIUM CHLORIDE BOTTLES IN THE KITS. THE LIQUID WAS DRIED UP BUT THERE WERE SHARDS OF GLASS IN THE KIT. ALL WITH THE SAME LOT NUMBER". ASSOCIATED COMPLAINTS 9680794-2025-00881, 9680794-2025-00886, 9680794-2025-00888, 9680794-2025-00889, 9680794-2025-00891, 9680794-2025-00892, 9680794-2025-00893, 9680794-2025-00894, 9680794-2025-00884, 9680794-2025-00885 AND 9680794-2025-00880.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434878 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT: "WE HAVE HAD SOME KITS ALL HAD BROKEN SODIUM CHLORIDE BOTTLES IN THE KITS. THE LIQUID WAS DRIED UP BUT THERE WERE SHARDS OF GLASS IN THE KIT. ALL WITH THE SAME LOT NUMBER". ASSOCIATED COMPLAINTS 9680794-2025-00881, 9680794-2025-00886, 9680794-2025-00888, 9680794-2025-00890, 9680794-2025-00891, 9680794-2025-00892, 9680794-2025-00893, 9680794-2025-00894, 9680794-2025-00884, 9680794-2025-00885 AND 9680794-2025-00880.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434789 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT: "WE HAVE HAD SOME KITS ALL HAD BROKEN SODIUM CHLORIDE BOTTLES IN THE KITS. THE LIQUID WAS DRIED UP BUT THERE WERE SHARDS OF GLASS IN THE KIT. ALL WITH THE SAME LOT NUMBER". ASSOCIATED COMPLAINTS 9680794-2025-00881, 9680794-2025-00886, 9680794-2025-00889, 9680794-2025-00890, 9680794-2025-00891, 9680794-2025-00892, 9680794-2025-00893, 9680794-2025-00894, 9680794-2025-00884, 9680794-2025-00885 AND 9680794-2025-00880.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434762 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT: "WE HAVE HAD SOME KITS ALL HAD BROKEN SODIUM CHLORIDE BOTTLES IN THE KITS. THE LIQUID WAS DRIED UP BUT THERE WERE SHARDS OF GLASS IN THE KIT. ALL WITH THE SAME LOT NUMBER". ASSOCIATED COMPLAINTS 9680794-2025-00881, .9680794-2025-00888, 9680794-2025-00889, 9680794-2025-00890, 9680794-2025-00891, 9680794-2025-00892, 9680794-2025-00893, 9680794-2025-00894, 9680794-2025-00884, 9680794-2025-00885 AND 9680794-2025-00880.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434720 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT: "WE HAVE HAD SOME KITS ALL HAD BROKEN SODIUM CHLORIDE BOTTLES IN THE KITS. THE LIQUID WAS DRIED UP BUT THERE WERE SHARDS OF GLASS IN THE KIT. ALL WITH THE SAME LOT NUMBER". ASSOCIATED COMPLAINTS 9680794-2025-00881, 9680794-2025-00886, 9680794-2025-00888, 9680794-2025-00889, 9680794-2025-00890, 9680794-2025-00891, 9680794-2025-00892, 9680794-2025-00893, 9680794-2025-00894, 9680794-2025-00884 AND 9680794-2025-00880.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434688 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT: "WE HAVE HAD 11 KITS ALL HAD BROKEN SODIUM CHLORIDE BOTTLES IN THE KITS. THE LIQUID WAS DRIED UP BUT THERE WERE SHARDS OF GLASS IN THE KIT. ALL WITH THE SAME LOT NUMBER". ASSOCIATED COMPLAINTS 9680794-2025-00881, 9680794-2025-00886, 9680794-2025-00888, 9680794-2025-00889, 9680794-2025-00890, 9680794-2025-00891, 9680794-2025-00892, 9680794-2025-00893, 9680794-2025-00894, AND 9680794-2025-00880.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434587 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT: "WE HAVE HAD 11 KITS ALL HAD BROKEN SODIUM CHLORIDE BOTTLES IN THE KITS. THE LIQUID WAS DRIED UP BUT THERE WERE SHARDS OF GLASS IN THE KIT. ALL WITH THE SAME LOT NUMBER". ASSOCIATED COMPLAINTS 9680794-2025-00881, 9680794-2025-00886, 9680794-2025-00888, 9680794-2025-00889, 9680794-2025-00890, 9680794-2025-00891, 9680794-2025-00892, 9680794-2025-00893, 9680794-2025-00894, 9 680794-2025-00884.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434550 ↗