TEMPO 451543V0Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705032008679), received between Aug 9, 2019 and Nov 10, 2025 — classified as 7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2025Degraded; Degraded

  AS REPORTED, THE BODY OF A 5F TEMPO ANGIOGRAPHIC CATHETERS WAS PEELING OFF, APPEARING AS THOUGH IT WAS DECOMPOSING. THERE WAS NO REPORTED PATIENT INJURY. IT WAS FURTHER REPORTED THAT ADDITIONAL DEVICES FROM THE SAME LOTS AND SKUS EXHIBITED SIMILAR PEELING, WITH APPROXIMATELY NINETEEN DEVICES AFFECTED. IT WAS CONFIRMED THAT THE REMAINING DEVICES WERE STERILE AND EXHIBITED THE SAME FAILURE. DEVICES ARE STORED IN THE WAREHOUSE ALONG WITH OTHER MEDICAL DEVICES. OZONE IS NOT USED TO DISINFECT, AND IT IS NOT USED IN ANY AREAS SUCH AS PROCEDURE OR STORAGE ROOMS. FOUR IMAGES WERE PROVIDED, SHOWING BLUE FLAKES ON A BLOOD-SOAKED SURGICAL TOWEL, CRACKS ON THE CATHETER BODY AND STRAIN RELIEF, AND YELLOWISH DISCOLORATION TO THE HUB. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510622 ↗
• MalfunctionJul 5, 2024Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, BY THE PURCHASING DEPARTMENT, A 5F 65CM TEMPO DIAGNOSTIC CATHETER WAS USED IN A PATIENT AND THE PRODUCT "BROKE". THE DAMAGE WAS DESCRIBED AS FRAYED, SPLIT TORN DURING USE IN THE PATIENT. THE DEVICE BROKE OFF AT THE BASE DURING ROTATION OF THE CATHETER AFTER A FEW ATTEMPTS, TRYING TO STEER THE CATHETER. ANOTHER PRODUCT WITH THE SAME LOT WAS TAKEN AND IT BROKE AGAIN. A THIRD PRODUCT WAS THEN TAKEN WHICH DID NOT BREAK. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS REPORTED AS ILIAC- SIDE BRANCH, PROBING OF THE VESSEL OF THE LEFT INTERNAL CAROTID ARTERY (ICA). THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DEVICE DAMAGE NOTICED PRIOR TO OPENING THE PACKAGE OR DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THERE WAS SEVERE LESION CALCIFICATION AND TORTUOSITY. THE DEVICES WERE DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19684981 ↗
• MalfunctionJul 5, 2024Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, BY THE PURCHASING DEPARTMENT, A 5F 65CM TEMPO DIAGNOSTIC CATHETER WAS USED IN A PATIENT AND THE PRODUCT "BROKE". THE DAMAGE WAS DESCRIBED AS FRAYED, SPLIT TORN DURING USE IN THE PATIENT. THE DEVICE BROKE OFF AT THE BASE DURING ROTATION OF THE CATHETER AFTER A FEW ATTEMPTS, TRYING TO STEER THE CATHETER. ANOTHER PRODUCT WITH THE SAME LOT WAS TAKEN AND IT BROKE AGAIN. A THIRD PRODUCT WAS THEN TAKEN WHICH DID NOT BREAK. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS REPORTED AS ILIAC- SIDE BRANCH, PROBING OF THE VESSEL OF THE LEFT INTERNAL CAROTID ARTERY (ICA). THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DEVICE DAMAGE NOTICED PRIOR TO OPENING THE PACKAGE OR DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THERE WAS SEVERE LESION CALCIFICATION AND TORTUOSITY. THE DEVICES WERE DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19684967 ↗
• MalfunctionAug 2, 2021Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  AS REPORTED, THE 5F 65CM COBRA (C2) TEMPO DIAGNOSTIC CATHETER WAS INTACT WHEN TAKEN OUT OF THE PACKAGING, BUT IT KINKED (SNAPPED) DURING PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE CATHETER WAS STORED CORRECTLY AND HANDLED WITH CARE WHILST REMOVING FROM THE PACKAGING. THE INTENDED PROCEDURE WAS A BRONCHIAL ARTERY EMBOLIZATION. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE PRODUCT, OR ANY OF THE OTHER DEVICES USED WITH IT, HAD NOT BEEN RESTERILIZED. A CONTRALATERAL APPROACH WAS NOT USED. THE TARGET SITE WAS THE BRONCHIAL ARTERIES. THE ACCESS SITE WAS A FEMORAL APPROACH. THE LESION WAS NOT CALCIFIED. THERE WAS NO VESSEL TORTUOSITY. THERE WAS NO STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WAS NO DIFFICULTY ADVANCING THE DEVICE THROUGH THE INTRODUCER OR THE GUIDEWIRE. THERE WAS NO DIFFICULTY ADVANCING THE DEVICE TO THE TARGET LESION. THERE WERE NO OTHER DEVICES USED WITH THE PRODUCT. NO EXCESSIVE TORQUING WAS REQUIRED. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12257799 ↗
• MalfunctionJul 27, 2021Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  AS REPORTED, TWO (2) 5F 65CM COBRA (C2) TEMPO DIAGNOSTIC CATHETERS WERE KINKED/CRACKED (SNAPPED) WHEN REMOVED FROM THE PATIENT. BOTH CATHETERS WERE INTACT WHEN REMOVED FROM THE PACKAGING AND HANDED TO THE DOCTOR BUT WHEN REMOVED FROM THE PATIENT THEY CAME OUT SNAPPED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE STORED PER LABELLING AND OPENED IN STERILE FIELD. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE DEVICE WAS PREPPED PER THE IFU. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE PRODUCT, OR ANY OF THE OTHER DEVICES USED WITH IT, HAD NOT BEEN RESTERILIZED. A CONTRALATERAL APPROACH WAS NOT USED. THE TARGET SITE WAS THE COMMON ILIAC. THE ACCESS SITE WAS FEMORAL. THE LESION WAS NOT CALCIFIED. THERE WAS NO VESSEL TORTUOSITY. THE WAS NO STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WAS NO DIFFICULTY ADVANCING THE DEVICE THROUGH THE INTRODUCER, OVER THE GUIDEWIRE, OR TO THE TARGET LESION. THE OTHER DEVICES USED WITH THE PRODUCT DID NOT KINK NOR BEND AT ANY TIME. THERE WAS NO UNUSUAL FORCE USED AT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230794 ↗
• MalfunctionJul 27, 2021Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  AS REPORTED, TWO (2) 5F 65CM COBRA (C2) TEMPO DIAGNOSTIC CATHETERS WERE KINKED/CRACKED (SNAPPED) WHEN REMOVED FROM THE PATIENT. BOTH CATHETERS WERE INTACT WHEN REMOVED FROM THE PACKAGING AND HANDED TO THE DOCTOR BUT WHEN REMOVED FROM THE PATIENT THEY CAME OUT SNAPPED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE STORED PER LABELLING AND OPENED IN STERILE FIELD. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE DEVICE WAS PREPPED PER THE IFU. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE PRODUCT, OR ANY OF THE OTHER DEVICES USED WITH IT, HAD NOT BEEN RESTERILIZED. A CONTRALATERAL APPROACH WAS NOT USED. THE TARGET SITE WAS THE COMMON ILIAC. THE ACCESS SITE WAS FEMORAL. THE LESION WAS NOT CALCIFIED. THERE WAS NO VESSEL TORTUOSITY. THE WAS NO STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WAS NO DIFFICULTY ADVANCING THE DEVICE THROUGH THE INTRODUCER, OVER THE GUIDEWIRE, OR TO THE TARGET LESION. THE OTHER DEVICES USED WITH THE PRODUCT DID NOT KINK NOR BEND AT ANY TIME. THERE WAS NO UNUSUAL FORCE USED AT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230754 ↗
• MalfunctionAug 9, 2019Difficult to Remove; Difficult to Remove

  AS REPORTED, A 5F C2 65CM TEMPO CATHETER COLLAPSED TWICE AND DID NOT RECOVER ITS ORIGINAL SHAPE WHICH HAS HINDERED THE REMOVAL OF THE CATHETER BY USING THE INTRODUCER. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS WITHDRAWN FROM THE PATIENT AND A PUNCTURE SITE HAS BEEN MADE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8879351 ↗