TEMPO 451435H0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032007986), received between Mar 15, 2021 and Jun 14, 2025 — 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. 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.

• InjuryJun 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING THE THORACIC AORTIC STENT IMPLANTATION SURGERY, THE TIP-END IMAGING RING OF A 4F HEADHUNTER 1 (H1) 100CM TEMPO DIAGNOSTIC CATHETER DETACHED AND FELL OFF INSIDE THE PATIENT'S BODY. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22208135 ↗
• MalfunctionMar 15, 2021Difficult to Remove; Difficult to Remove

  AS REPORTED, THE 4F 100CM TEMPO HEADHUNTER I (H1) ANGIOGRAPHIC CATHETER DOUBLED OVER ON ITSELF AND WOULD THEN NOT UNKINK. THERE WAS UNUSUAL FORCE USED DURING THE PROCEDURE. AS THE CATHETER HAD BECOME SEVERELY TWISTED AND KINKED, IT WAS NOT EASY TO REMOVE; THEREFORE, SOME FORCE WAS APPLIED TO REMOVE THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS OPENED IN STERILE FIELD. THE INTENDED PROCEDURE WAS A CEREBRAL ANGIOGRAM. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE DEVICE NOTICED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE DEVICE WAS PREPPED PER THE IFU. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE PRODUCT, NOR ANY OF THE OTHER DEVICES USED WITH IT, HAD NOT BEEN RESTERILIZED. THERE WERE NO ANOMALIES NOTED PRIOR TO INSERTING INTO THE PATIENT. THE TARGET SITE WAS THE CAROTID ARTERY. THE ACCESS SITE WAS FEMORAL. THE LESION WAS NOT CALCIFIED. THERE WAS SOME MODERATE ILIAC TORTUOSITY. THERE WAS NO STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WAS NO DIFFICULTY ADVANCING THE DEVI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11488108 ↗