ARROW IPN920501Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10801902195422), received between Jul 30, 2026 and Sep 16, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (3 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Device Damaged Prior to Use; Material Twisted/Bent

  It was reported that during inspection of the arterial catheter set, the guidewire was observed to be bent. A new arterial catheter set was obtained and the procedure was completed without reported complications. The issue was identified prior to patient use, and the device was not used. There was no patient involvement and no reports of patient injury, adverse health consequences, or clinically significant harm associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782606 ↗
• MalfunctionSep 16, 2026Device Damaged Prior to Use; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782556 ↗
• MalfunctionSep 16, 2026Device Damaged Prior to Use; Material Twisted/Bent

  It was reported that after opening the arterial catheter packaging, the guidewire was observed to be folded/bent. The issue was detected before patient use, and the device was not used. There was no patient involvement and no patient injury, adverse health consequences, or clinically significant harm associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782530 ↗
• MalfunctionSep 3, 2026Unraveled Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50577504 ↗
• InjuryJul 30, 2026Incorrect Measurement; Material Separation

  Patient problems: Foreign Body In Patient

  MAUDE report 50090928 ↗