ARROW IPN000102Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801902008756), received between Sep 7, 2023 and Sep 7, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Flush” (1 report).

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.

• MalfunctionSep 7, 2023Difficult to Flush; Difficult to Flush

  REPORTED AS "DEFECT IN THE DISTAL PORT AND WAS DIFFICULT TO FLUSH". THE REPORT STATES THAT "THE SWAN WAS PRE-TESTED OUTSIDE THE BODY. ALL LUMENS FLUSHED. ONCE INSERTED INTO PATIENT, SWAN WAS ASPIRATED AND PRESSURES WERE RECORDED. THERMO OUTPUTS WERE BEING RECORDED WHEN ISSUE WAS NOTICED. TECH WAS UNABLE TO PUSH FLUID THROUGH DISTAL TIP AT A REGULAR TIMELINE. NORMAL FLUSH IS 3-4 SECONDS. THIS WAS TAKING OVER 7-8 SECONDS WHICH WAS MAKING THE THERMO INCORRECT. THE STAFF ASPIRATED AND TRIED AGAIN WITH SAME OUTCOME. THE PHYSICIAN THEN TRIED WITH SIMILAR RESULTS. THE CATHETER WAS REPOSITIONED WITH SAME OUTCOME. THE CATHETER WAS REMOVED AND CHECKED FOR KINKS OR VISIBLE DEFECT NONE WAS SEEN. NO HARM CAME TO THE PATIENT ALTHOUGH AN IMPROPER OUTCOME RESULTED FROM PROCEDURE DUE TO ISSUE WITH SWAN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17703412 ↗