TEMPO 451442V0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032008020), received between Jun 29, 2023 and Jun 29, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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.

• MalfunctionJun 29, 2023Leak/Splash; Leak/Splash

  AS REPORTED, A 4F 65CM TEMPO COBRA ¿ CHILD 1 (C1) DIAGNOSTIC CATHETER WAS DRAWING BACK AIR WHEN CONNECTED TO A MECHANICAL CONTRAST PUMP. AS A RESULT, A NEW 4F 65CM TEMPO COBRA C1 DIAGNOSTIC CATHETER WAS USED AS A REPLACEMENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS IN THE ILIAC ARTERY WHEN THE DRAW BACK WAS BEING PERFORMED AND THE TIP OF THE CATHETER WAS SITTING FREELY WITHIN THE VESSEL. THERE WERE NO SIGNS OF CALCIFICATION, STENOSIS, OR TORTUOSITY PRESENT IN THE TARGET VESSEL. A NON-CORDIS HIGH PRESSURE TUBING WAS USED. THERE WAS NO DIFFICULTY CONNECTING THE TUBING TO THE TEMPO CATHETER AND NO LEAKAGE WAS OBSERVED AT EITHER END OF THE HIGH-PRESSURE TUBING. THE MALFUNCTION OCCURRED PRIOR TO TAKING AN ANGIOGRAM WITH THE C1 CATHETER; HOWEVER, ONE ¿PIGTAIL RUN¿ WAS PERFORMED PRIOR TO THE USE OF THE C1 CATHETER. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY FLUSHING THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17228380 ↗