TEMPO SRD5497Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032048422), received between Nov 25, 2020 and Nov 25, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2020Difficult to Remove; Difficult to Remove

  AS REPORTED, THE HEAD OF THE 4F 0.038 80CM HEPATIC TEMPO ANGIOGRAPHIC CATHETER WAS DEFORMED (KINKED/BENT); IT CANNOT BE PASSED THROUGH THE LESION. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED INSIDE THE PATIENT. A LITTLE RESISTANCE WAS MET WHILE ADVANCING THE DEVICE AND WITHDRAWING THE DEVICE. THE INTENDED PROCEDURE/TARGET LESION WAS THE CAROTID ARTERY. THE LESION WAS NOT CALCIFIED NOR TORTUOUS AND HAD NO VESSEL ANGULATION. THE PERCENTAGE OF STENOSIS WAS 70%. THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE WAS RESTERILIZED. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. NO EXCESSIVE FORCE WAS REQUIRED. THE DEVICE WAS REMOVED FROM THE PATIENT AS NORMAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10905746 ↗