TEMPO 451531H2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032008594), received between Mar 22, 2021 and Feb 25, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionFeb 25, 2022Difficult to Remove; Difficult to Remove

  AS REPORTED, A 5F TEMPO SIM 2 100CM 2SH DIAGNOSTIC CATHETER WAS FOUND TO BE KINKED AS IT WAS REMOVED FROM THE STERILE PACKAGING AND WOULD NOT ALLOW AN UNKNOWN GUIDEWIRE TO ADVANCE. IT WAS ALSO REPORTED THAT THE 5F TEMPO CATHETER WAS DIFFICULT TO REMOVE FROM THE PATIENT. AFTER THE 5F TEMPO CATHETER WAS REMOVED, AN UNKNOWN CATHETER WAS ABLE TO BE USED SUCCESSFULLY AND THERE WAS NO INJURY TO THE PATIENT. IT WAS REPORTED THAT THERE WAS SUSPICION THE DEVICE WAS DAMAGED IN TRANSIT SINCE THE KINK WAS OBSERVED DURING REMOVAL FROM ITS PACKAGING. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). INFORMATION REGARDING THE DEVICE LOT NUMBER, ACCESS SITE, ACCESS VESSEL CHARACTERISTICS, CONCOMITANT MEDICAL DEVICES, AND THE COMPLETION OF THE PROCEDURE WAS REQUESTED BUT IS NOT AVAILABLE AND THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13606936 ↗
• InjuryMar 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  UPON TORQUEING A 5F 100CM SIDEWINDER SIMMONS TECHNIQUE II (SIM2) TEMPO DIAGNOSTIC CATHETER TO POSITION TO THE AORTIC ARCH, THE BODY OF THE CATHETER SHEARED, APPEARING TO HAVE CAUGHT ON THE EDGE OF THE LEFT ILIAC PORTION OF THE ENDOGRAFT STENT AND SEPARATING INTO TWO HALVES. THEREFORE, THE PROXIMAL END OF THE CATHETER WAS REMOVED THROUGH THE 5F 23CM BRITE TIP SHEATH WITH GUIDEWIRE ACCESS MAINTAINED THROUGH THE DISTAL PORTION OF THE CATHETER. RIGHT FEMORAL ACCESS WAS ACHIEVED WITH AN 8F 45CM UNKNOWN SHEATH AND PROCEED TO THE AAA ENDOGRAFT INTO THE THORACIC AORTA. AN UNKNOWN LOOP SNARE WAS PASSED THROUGH THIS SHEATH UP TO THE AORTIC ARCH AND THE SNARE WAS MANIPULATED THROUGH THE DISTAL TIP OF THE TEMPO CATHETER. ONCE SNARED, THE TEMPO CATHETER WAS REMOVED THROUGH THE 8F SHEATH AND THE REMAINDER OF THE DIAGNOSTIC PROCEDURE WAS ABLE TO BE COMPLETED WITHOUT ANY ADVERSE EVENT. INITIALLY, THE DOCTOR BEGAN WITH THE LEFT FEMORAL ACCESS WITH A 5F 23CM BRITE TIP SHEATH INTRODUCER FOR A DIAGNOSTIC CEREBRAL ARTERY. A NON-CORDIS GLIDE WIRE PASSED THROUGH THE SHEATH WITH A 5F 100CM SIM2 TEMPO DIAGNOSTIC CATHETER AND THE CATHETER WAS ADVANCED THROUGH PREVIOUSLY PLACED AAA ENDOGRAFT UP TO THE ARCH F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11544333 ↗