ARROW IPN030069Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801902100115), received between Nov 21, 2023 and Nov 21, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2023Break; Gas/Air Leak; Break; Gas/Air Leak

  IT WAS REPORTED THAT "NEEDLE FROM THE KIT FAILED TO WORK. DURING INSERTION OF THE NEEDLE IN THE JUGULAR VEIN THERE WERE SOME AIR LEAKS. THE NEEDLE WAS PROPERLY PLACED IN THE VEIN BUT THERE WAS NO BLOOD FLOW, JUST AIR. THE INSERTION WAS DONE UNDER SUPERVISION AND NEEDLE WAS PUNCTURE CORRECTLY. MALE PATIENT. CLINICAL CONSEQUENCES: NONE. DEVICE REPLACED". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18183368 ↗

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