TEMPO SRD5602Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705032048644), received between Jun 27, 2022 and Jun 28, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (4 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.

• InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem; Therapeutic or Diagnostic Output Failure

  AS REPORTED, CARDIOLOGISTS REPORTED 4 (FOUR) DIFFERENT CASES OF AORTIC DISSECTIONS WHILE USING THE 5F TEMPO (5F TEMPO 0.038 100C BL) BRACHIAL LEFT CATHETER. THREE (3) DIFFERENT CARDIOLOGISTS FROM THE SAME HOSPITAL RECENTLY REPORTED THE SAME KIND OF COMPLICATION ALL WITH PRODUCT CODE SRD5602. THEY HAVE BEEN USING THIS PRODUCT FOR YEARS. THE INCIDENT WAS REPORTED AT THE DUTCH HEALTH CARE INSPECTORATE AND CARDIOLOGISTS ARE CALLING OTHER DOCTORS TO SEE IF THEY HAVE EXPERIENCED THE SAME KIND OF COMPLICATION WITH THIS CATHETER. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THIS CASE IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 14841079 ↗
• InjuryJun 27, 2022Therapeutic or Diagnostic Output Failure

  AS REPORTED, CARDIOLOGISTS REPORTED 4 (FOUR) DIFFERENT CASES OF AORTIC DISSECTIONS WHILE USING THE 5F TEMPO (5F TEMPO 0.038 100C BL) BRACHIAL LEFT CATHETER. THREE (3) DIFFERENT CARDIOLOGISTS FROM THE SAME HOSPITAL RECENTLY REPORTED THE SAME KIND OF COMPLICATION ALL WITH PRODUCT CODE SRD5602. THEY HAVE BEEN USING THIS PRODUCT FOR YEARS. THE INCIDENT WAS REPORTED AT THE DUTCH HEALTH CARE INSPECTORATE AND CARDIOLOGISTS ARE CALLING OTHER DOCTORS TO SEE IF THEY HAVE EXPERIENCED THE SAME KIND OF COMPLICATION WITH THIS CATHETER. THE DEVICE IS EXPECTED TO BE RETURN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 14832164 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem; Therapeutic or Diagnostic Output Failure

  AS REPORTED, CARDIOLOGISTS REPORTED 4 (FOUR) DIFFERENT CASES OF AORTIC DISSECTION WHILE USING THE 5F TEMPO (5F TEMPO 0.038 100C BL) BRACHIAL LEFT CATHETER. THREE (3) DIFFERENT CARDIOLOGISTS FROM THE SAME HOSPITAL RECENTLY REPORTED THE SAME KIND OF COMPLICATION ALL WITH PRODUCT CODE SRD5602. THEY HAVE BEEN USING THIS PRODUCT FOR YEARS. THE INCIDENT WAS REPORTED AT THE DUTCH HEALTH CARE INSPECTORATE AND CARDIOLOGISTS ARE CALLING OTHER DOCTORS TO SEE IF THEY HAVE EXPERIENCED THE SAME KIND OF COMPLICATION WITH THIS CATHETER. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THIS CASE IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 14831088 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem; Therapeutic or Diagnostic Output Failure

  AS REPORTED, CARDIOLOGISTS REPORTED 4 (FOUR) DIFFERENT CASES OF AORTIC DISSECTION WHILE USING THE 5F TEMPO (5F TEMPO 0.038 100C BL) BRACHIAL LEFT CATHETER. THREE (3) DIFFERENT CARDIOLOGISTS FROM THE SAME HOSPITAL RECENTLY REPORTED THE SAME KIND OF COMPLICATION ALL WITH PRODUCT CODE SRD5602. THEY HAVE BEEN USING THIS PRODUCT FOR YEARS. THE INCIDENT WAS REPORTED AT THE (B)(6) HEALTH CARE INSPECTORATE AND CARDIOLOGISTS ARE CALLING OTHER DOCTORS TO SEE IF THEY HAVE EXPERIENCED THE SAME KIND OF COMPLICATION WITH THIS CATHETER. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THIS CASE IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 14830911 ↗