TEMPO 451406P0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032007757), received between Oct 12, 2020 and Nov 6, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2024Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging

  AS REPORTED, THE INNER POUCH PACKAGING OF A 4F MULTI-PURPOSE A1 (I) 125CM TEMPO DIAGNOSTIC CATHETER WAS DAMAGED. THE STERILE POUCH WAS RECEIVED OPEN/COMPROMISED. THE PRODUCT WAS UNUSED. IT IS NOT POSSIBLE THAT THE PRODUCT HAD BEEN PURPOSELY OPENED IN ANTICIPATION OF USE AND THEN RESHELVED. THE CONDITION WAS NOTED AFTER IT HAD BEEN RECEIVED AND STORED IN THE LAB PRIOR TO USE. IN THE LAB, IT WAS STORED IN THE CATH LAB AND MANAGED BY A SPECIALIST. THE ACTUAL PRODUCT WAS NOT DAMAGED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20619758 ↗
• MalfunctionOct 12, 2020Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material

  AS REPORTED, THE PACKAGING OF 125CM MULTIPURPOSE (MP) A1 TEMPO ANGIOGRAPHIC CATHETER THAT INCLUDES THE STERILE PACKAGING WAS DAMAGED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE OUTER PRODUCT BOX AND THE INNER STERILE POUCH WAS CRACKED. THE INTEGRITY OF THE STERILE POUCH WAS COMPROMISED. THE DAMAGE WAS NOTED AFTER IT HAD BEEN RECEIVED AND STORED IN THE LAB PRIOR TO USING. THE ACTUAL PRODUCT WAS NOT DAMAGED. THE PRODUCT WAS NOT USED IN PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10663296 ↗