ARROW IPN036260Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902121346), received between Oct 12, 2023 and Oct 12, 2023 — classified as 1 malfunction.

1 other recall cover devices cleared under the same FDA submission (K895268); 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.

• MalfunctionOct 12, 2023

  PATIENT ARRIVED FROM THE OPERATING ROOM AND THE SWAN WAS WORKING IN OBTAINING PA PRESSURES, BUT NURSING STAFF WERE UNABLE TO OBTAIN ANY CO/CI NUMBERS. ON CLOSER INSPECTION THEY FOUND BLOOD OOZING OUT OF THE WIRING PORT THAT CONNECTS THE SWAN TO THE MONITOR, THE BEIGE PORT ON THE YELLOW LUMEN OF THE SWAN. THE SWAN WAS THEN REMOVED WHERE ALL THE COMPONENTS WERE INTACT, BEFORE BEING REPLACED WITH A NEW ONE BY THE OVERNIGHT SURGICAL ICU PHYSICIAN. THE MALFUNCTIONED SWAN WAS PLACED INTO A SPECIMEN BAG AND GIVEN TO SICU MANAGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919448 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K895268. One submission often covers many models, so check the product and lot details in each record.

• Z-0331-2017 · Sep 2, 2016 · Terminated
  HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/ballo