TEMPO 451443V0Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705032008051), received between Apr 13, 2022 and Nov 19, 2025 — classified as 4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, A 4F C2 65CM TEMPO DIAGNOSTIC CATHETER WAS SEVERED BY THE PUNCTURE. THERE WAS NO REPORTED PATIENT INJURY. THIS OCCURRED DURING A LUMBAR EMBOLIZATION. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS THE DEVICE WAS DESTROYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23600990 ↗
• MalfunctionApr 15, 2024Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  AS REPORTED, THE CUSTOMER REPORTED FINDING 4F TEMPO 65 CM ANGIOGRAPHIC CATHETERS STILL IN STERILE PACKAGE: HOWEVER, DAMAGED, AND UNUSABLE. THEY CLAIM TO HAVE RECEIVED THE PRODUCT IN THIS FASHION. A PICTURE SHOWING THREE (3) STERILE TEMPO CATHETERS WAS PROVIDED FOR REVIEW AND PIECES OF THE COATING ON THE CATHETERS APPEAR TO BE FLAKING OFF THE DEVICES. THE PRODUCTS WERE NEVER OPENED OR USED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE EXACT EVENT DATE IS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) TEMPO CATHETERS OF LOT NUMBER 18168805. THE CONDITION WAS NOTICED PRIOR TO USE. THERE WAS NO DAMAGE TO THE SHIPPING BOX, NO DAMAGE TO THE OUTER PRODUCT BOX OR THE INNER PRODUCT POUCH. THE STERILE POUCH WAS NOT RECEIVED OPEN/COMPROMISED. THE PRODUCTS ARE STORED IN THE LAB HANGING IN RACKS. THE DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19111839 ↗
• MalfunctionApr 15, 2024Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  AS REPORTED, THE CUSTOMER REPORTED FINDING 4F TEMPO 65 CM ANGIOGRAPHIC CATHETERS STILL IN STERILE PACKAGE: HOWEVER, DAMAGED, AND UNUSABLE. THEY CLAIM TO HAVE RECEIVED THE PRODUCT IN THIS FASHION. A PICTURE SHOWING THREE (3) STERILE TEMPO CATHETERS WAS PROVIDED FOR REVIEW AND PIECES OF THE COATING ON THE CATHETERS APPEAR TO BE FLAKING OFF THE DEVICES. THE PRODUCTS WERE NEVER OPENED OR USED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE EXACT EVENT DATE IS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) TEMPO CATHETERS OF LOT NUMBER 18168805. THE CONDITION WAS NOTICED PRIOR TO USE. THERE WAS NO DAMAGE TO THE SHIPPING BOX, NO DAMAGE TO THE OUTER PRODUCT BOX OR THE INNER PRODUCT POUCH. THE STERILE POUCH WAS NOT RECEIVED OPEN/COMPROMISED. THE PRODUCTS ARE STORED IN THE LAB HANGING IN RACKS. THE DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19111631 ↗
• MalfunctionApr 13, 2022Crack; Crack

  DURING PREP, THE HUB OF THE TEMPO CATHETER WAS DAMAGED (CRACKED) WHEN THE CATHETER WAS UNPACKED. THERE WAS NO PATIENT INJURY. ANOTHER UNKNOWN CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DAMAGES NOTED TO THE PACKAGING. THE CATHETER WAS HANDLED ACCORDING TO THE INSTRUCTION FOR USE (IFU) WITH NO FORCE NEEDED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14107548 ↗