TEMPO 451406H0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705032007740), received between Jul 3, 2024 and Nov 5, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Degraded; Degraded

  AS REPORTED, A 5 F TEMPO AQUA 0.038" 65CM CATHETER BEGAN CRUMBLING DURING A PROCEDURE. THE CATHETER WAS NOT USED AT THE TIME OF NOTICING THE FLAKING. A DIFFERENT UNKNOWN CATHETER WAS USED. THE PATIENT LATER EXPIRED THAT DAY. IT IS STATED THAT THE TECH WIPED HIS HANDS AND NOTICED BLUE FLAKES ON HIS GLOVES AND CHECKED THE CATHETER AND NOTICED IT WAS "CRUMBLING", AND THAT NONE OF THE CATHETER FLAKED OFF IN THE PATIENT'S BODY, JUST ON THE STERILE FIELD. THE CATHETER DID NOT FLAKE OFF INSIDE THE PATIENT¿S BODY; THE FLAKING OCCURRED ON THE STERILE FIELD AND WAS NOTICED DURING THE PROCEDURE BEFORE BEING PASSED TO THE PHYSICIAN. THE DEVICE WAS PREPPED AND FLUSHED, WITH NO DIFFICULTIES ENCOUNTERED DURING PREPARATION. THERE WAS NO NEED TO REPLACE THE STERILE FIELD, GLOVES, OR GOWN AFTER NOTICING THE FLAKING. THE PROCEDURE WAS A PERIPHERAL INTERVENTION CONDUCTED ON AN OUTPATIENT BASIS FOR PERIPHERAL ARTERY DISEASE (PAD). THE PATIENT DIED DUE TO AN ACCESS SITE BLEED AND EXHIBITED HYPOTENSION PRIOR TO EXPIRING. THE DEVICE WAS NOT EXPOSED TO HEAT OR STORED IN A DARK LOCATION, AND THE FACILITY DOES NOT USE UV LIGHTING OR OZONE FOR STERILIZATION OR MICROBIAL REDUCTION. THE TARGET SITE WAS THE COMM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478673 ↗
• MalfunctionNov 5, 2025Degraded; Degraded

  AS REPORTED, A 5 F TEMPO AQUA 0.038" 65CM CATHETER BEGAN CRUMBLING DURING A PROCEDURE. THE CATHETER WAS NOT USED AT THE TIME OF NOTICING THE FLAKING. A DIFFERENT UNKNOWN CATHETER WAS USED. THE PATIENT LATER EXPIRED THAT DAY. IT IS STATED THAT THE TECH WIPED HIS HANDS AND NOTICED BLUE FLAKES ON HIS GLOVES AND CHECKED THE CATHETER AND NOTICED IT WAS "CRUMBLING", AND THAT NONE OF THE CATHETER FLAKED OFF IN THE PATIENT'S BODY, JUST ON THE STERILE FIELD. THE CATHETER DID NOT FLAKE OFF INSIDE THE PATIENT¿S BODY; THE FLAKING OCCURRED ON THE STERILE FIELD AND WAS NOTICED DURING THE PROCEDURE BEFORE BEING PASSED TO THE PHYSICIAN. THE DEVICE WAS PREPPED AND FLUSHED, WITH NO DIFFICULTIES ENCOUNTERED DURING PREPARATION. THERE WAS NO NEED TO REPLACE THE STERILE FIELD, GLOVES, OR GOWN AFTER NOTICING THE FLAKING. THE PROCEDURE WAS A PERIPHERAL INTERVENTION CONDUCTED ON AN OUTPATIENT BASIS FOR PERIPHERAL ARTERY DISEASE (PAD). THE PATIENT DIED DUE TO AN ACCESS SITE BLEED AND EXHIBITED HYPOTENSION PRIOR TO EXPIRING. THE DEVICE WAS NOT EXPOSED TO HEAT OR STORED IN A DARK LOCATION, AND THE FACILITY DOES NOT USE UV LIGHTING OR OZONE FOR STERILIZATION OR MICROBIAL REDUCTION. THE TARGET SITE WAS THE COMM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475646 ↗
• MalfunctionJul 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TIP END OF A 4F MULTI-PURPOSE (MP) A1100CM TEMPO DIAGNOSTIC CATHETER WAS FOUND TO BE SEPARATED INTO TWO PIECES. THE PRODUCT WAS SUBSEQUENTLY DISCARDED, AND AN INTACT UNKNOWN CONTRAST CATHETER WAS USED. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE ISSUE WAS DISCOVERED PRIOR TO PERFORMING AN ANGIOGRAM ON THE PATIENT, UPON INSPECTION OF THE CATHETER, PRIOR TO DELIVERY OF THE DEVICE INTO THE BODY. THE PRODUCT WAS NOT INSERTED INTO THE PATIENT. THE PATIENT WAS NOT INJURED. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DAMAGES FOUND ON THE DEVICE PACKAGING. THE DEVICE WAS NOT PULLED FROM THE PACKAGING BY THE HUB. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19666289 ↗