TEMPO 451503F5Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032008266), received between Dec 10, 2025 and Dec 10, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Degraded” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Degraded; Degraded

  AS REPORTED, THE BLUE COVER OF TWO 5F PITGTAIL 90CM 5 SIDE HOLES AND ONE 5F BERENSTEIN II 100CM TEMPO DIAGNOSTIC CATHETERS WERE PEELING. THERE WAS NO REPORTED PATIENT INJURY AS THEY WERE NOT USED ON A PATIENT. THE DEVICES WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770084 ↗
• MalfunctionDec 10, 2025Degraded; Degraded

  AS REPORTED, THE BLUE COVER OF TWO 5F PITGTAIL 90CM 5 SIDE HOLES AND ONE 5F BERENSTEIN II 100CM TEMPO DIAGNOSTIC CATHETERS WERE PEELING. THERE WAS NO REPORTED PATIENT INJURY AS THEY WERE NOT USED ON A PATIENT. THE DEVICE EXHIBITED FLAKING IN MULTIPLE AREAS, AND THE DEVICE HAD BEEN STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICES ARE KEPT INSIDE DEDICATED CATHETER STORAGE CABINETS, STORED EITHER OUTSIDE THEIR WHITE OUTER BOXES WHEN SPACE ALLOWS OR WITHIN THE BOXES WHEN NECESSARY, AND THE CABINETS HAVE WOODEN DOORS THAT KEEP THE INTERIOR DARK. THE DISTRIBUTOR STORES THE MATERIAL IN A CLIMATE-CONTROLLED ENVIRONMENT, AFTER WHICH IT IS DELIVERED TO THE HOSPITAL PHARMACY AND SUBSEQUENTLY TRANSFERRED TO THE INTERVENTIONAL RADIOLOGY DEPARTMENT FOR STORAGE IN ITS WAREHOUSE. THE DEVICE IS NOT REPROCESSED OR RESTERILIZED, NOR IS IT EXPOSED TO UV LIGHTING OR ANY STERILIZATION PROCESS, AND THE LAB DOES NOT USE SUCH PROCESSES. THERE WERE NO OTHER DEVICES IN THE BOX TO EXAMINE. OZONE IS NOT USED FOR DISINFECTION IN ANY AREA. THE DEVICES WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767794 ↗