TEMPO SRD6892Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032051774), received between Sep 19, 2017 and Mar 28, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionMar 28, 2025Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  AS REPORTED, THERE WERE MULTIPLE HOLES THROUGHOUT THE LENGTH OF A 5F 125CM 135-DEGREE VERTEBRAL (VERT) TEMPO DIAGNOSTIC CATHETER. THE DAMAGE TO THE CATHETER WAS OBSERVED DURING A CEREBRAL ANGIOGRAM, AND THE CATHETER WAS IN THE RIGHT M2 VESSEL WHEN THE DAMAGE WAS OBSERVED. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DAMAGE TO THE DEVICE PACKAGING. THE VESSEL CHARACTERISTICS WERE NON-CALCIFIED, NON-TORTUOUS, AND HAD 0% STENOSIS. THE DEVICE WAS NEVER PLACED IN AN ACUTE BEND DURING ITS USE IN THE PATIENT, AND THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PATIENT. THE DEVICE HAS NOW BEEN RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720353 ↗
• MalfunctionSep 19, 2017Detachment Of Device Component; Detachment Of Device Component

  DURING A STROKE INTERVENTION CASE, A 5F TEMPO VERTEBRAL 135 DEGREE CATHETER WAS BEING PREPPED. THE CATHETER WAS PLACED INSIDE A NON-CORDIS GUIDE CATHETER AND THE MD NOTICED THAT CATHETER RADIOPAQUE TIP WAS NON EXISTENT AND REMOVED CATHETER OUT OF GUIDE CATHETER. BY PLACING A BRAND NEW VERTEBRAL CATHETER, MD FLUORO¿D PRIOR TO TREATMENT AND NOTICED THE BROKEN TIP WAS INTACT AND INSIDE THE GUIDE CATHETER. HE THEN CONTINUED TO REMOVE BOTH CATHETERS OUT SUCCESSFULLY WITHOUT PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6875693 ↗