TEMPO 451532H0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705032008600), received between Jan 28, 2026 and Jan 28, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Crack” (3 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.

• MalfunctionJan 28, 2026Crack; Degraded; Detachment of Device or Device Component

  AS REPORTED, THE DISTAL PORTION AT THE CURVE OF A 5F 100 CM TEMPO CORONARY GUIDING CATHETER WAS OBSERVED TO HAVE A CRACK UPON OPENING THE PACKAGE AND SUBSEQUENTLY BROKE WHEN EXAMINED. THE DEVICE WAS NOT USED, AND ANOTHER TEMPO PRODUCT WAS SELECTED. THERE WAS NO REPORTED PATIENT INJURY. THE NURSE AND PHYSICIAN NOTED THAT THE CATHETER FELT VERY DRY, AND SIMILAR FINDINGS WERE OBSERVED WITH THREE CATHETERS FROM TWO DIFFERENT BATCHES, WHILE A CATHETER FROM ANOTHER BATCH WAS FOUND TO BE INTACT. THE PRODUCTS WERE PROPERLY STORED AND OPENED IN STERILE FIELD. NO DEVICE DAMAGE WAS OBSERVED PRIOR TO OPENING THE PACKAGE, AND NO DIFFICULTY WAS ENCOUNTERED IN REMOVING THE DEVICE FROM ITS STERILE PACKAGING. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND NO ISSUES WERE EXPERIENCED DURING PREPARATION. TWO IMAGES WERE PROVIDED SHOWING A CRACK AT THE DISTAL PORTION OF THE CATHETER. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201092 ↗
• MalfunctionJan 28, 2026Crack; Degraded; Detachment of Device or Device Component

  AS REPORTED, THE DISTAL PORTION AT THE CURVE OF A 5F 100 CM TEMPO CORONARY GUIDING CATHETER WAS OBSERVED TO HAVE A CRACK UPON OPENING THE PACKAGE AND SUBSEQUENTLY BROKE WHEN EXAMINED. THE DEVICE WAS NOT USED, AND ANOTHER TEMPO PRODUCT WAS SELECTED. THERE WAS NO REPORTED PATIENT INJURY. THE NURSE AND PHYSICIAN NOTED THAT THE CATHETER FELT VERY DRY, AND SIMILAR FINDINGS WERE OBSERVED WITH THREE CATHETERS FROM TWO DIFFERENT BATCHES, WHILE A CATHETER FROM ANOTHER BATCH WAS FOUND TO BE INTACT. THE PRODUCTS WERE PROPERLY STORED AND OPENED IN STERILE FIELD. NO DEVICE DAMAGE WAS OBSERVED PRIOR TO OPENING THE PACKAGE, AND NO DIFFICULTY WAS ENCOUNTERED IN REMOVING THE DEVICE FROM ITS STERILE PACKAGING. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND NO ISSUES WERE EXPERIENCED DURING PREPARATION. TWO IMAGES WERE PROVIDED SHOWING A CRACK AT THE DISTAL PORTION OF THE CATHETER. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201070 ↗
• MalfunctionJan 28, 2026Crack

  AS REPORTED, THE DISTAL PORTION AT THE CURVE OF A 5F 100 CM TEMPO CORONARY GUIDING CATHETER WAS OBSERVED TO HAVE A CRACK UPON OPENING THE PACKAGE AND SUBSEQUENTLY BROKE WHEN EXAMINED. THE DEVICE WAS NOT USED, AND ANOTHER TEMPO PRODUCT WAS SELECTED. THERE WAS NO REPORTED PATIENT INJURY. THE NURSE AND PHYSICIAN NOTED THAT THE CATHETER FELT VERY DRY, AND SIMILAR FINDINGS WERE OBSERVED WITH THREE CATHETERS FROM TWO DIFFERENT BATCHES, WHILE A CATHETER FROM ANOTHER BATCH WAS FOUND TO BE INTACT. THE PRODUCTS WERE PROPERLY STORED AND OPENED IN STERILE FIELD. NO DEVICE DAMAGE WAS OBSERVED PRIOR TO OPENING THE PACKAGE, AND NO DIFFICULTY WAS ENCOUNTERED IN REMOVING THE DEVICE FROM ITS STERILE PACKAGING. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND NO ISSUES WERE EXPERIENCED DURING PREPARATION. TWO IMAGES WERE PROVIDED SHOWING A CRACK AT THE DISTAL PORTION OF THE CATHETER. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24200982 ↗