TEMPO 451506H0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032008334), received between Mar 25, 2020 and May 24, 2024 — 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.

• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, WHILE ESTABLISHING A TRACK FOR THE DELIVERY OF AN UNKNOWN PATENT DUCTUS ARTERIOSUS (PDA) OCCLUDER WITH A 5F 100CM MULTIPURPOSE (MPA) TEMPO DIAGNOSTIC CATHETER, THE PATIENT¿S HEART RATE DROPPED TO 30 BEATS PER MINUTE, AND OXYGENATION DROPPED TO UNMEASURABLE LEVELS. A BEDSIDE CARDIAC ULTRASOUND WAS PERFORMED AND REVEALED A PERICARDIAL EFFUSION. THE DEVICE WAS REMOVED AND A PERICARDIOCENTESIS WAS PERFORMED. BLOODY FLUID WAS EXTRACTED, AND THE PATIENT WAS OBSERVED; HOWEVER, THE EFFUSION CONTINUED TO GRADUALLY INCREASE AFTER THE EXTRACTION OF FLUID. THE PATIENT¿S HEART RATE AND OXYGEN LEVELS RETURNED TO NORMAL, BUT DUE TO THE PERICARDIAL EFFUSION CONTINUING TO INCREASE, EMERGENCY CARDIAC SURGERY WAS PERFORMED. THE SURGICAL PROCEDURE WAS SUCCESSFUL, AND THE PATIENT WAS DISCHARGED AFTER THE SURGERY. THE TEMPO CATHETER WAS USED TO DELIVER THE UNKNOWN PDA OCCLUDER. THERE WAS NO DIFFICULTY PLACING THE UNKNOWN PDA OCCLUDER THROUGH THE 5F TEMPO CATHETER. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED. THE HOSPITAL REPORTED IT AS AN ADVERSE EVENT TO THE CHINA NMPA DIRECTLY.

  Patient problems: Pericardial Effusion

  MAUDE report 19392472 ↗
• MalfunctionMar 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING PHLEBOGRAPHY PROCEDURE, THE 5F 100CM TEMPO CATHETER HAD DIFFICULTY PASSING THROUGH THE ANATOMY AND FRACTURED WHEN ROTATED WHICH BEING LEFT IN TWO. THE FRACTURED PART WAS RECOVERED BY THE DOCTOR BY PULLING EVERYTHING AS SEPARATION STARTED NEAR THE INTRODUCER AND THE GUIDEWIRE WAS INSIDE THE CATHETER. IT DID NOT REQUIRE SECONDARY INTERVENTION. ANOTHER CATHETER WAS PASSED AND THE CASE COULD BE COMPLETED. THERE WAS NO VESSEL INJURY. THE PATIENT¿S CURRENT CONDITION IS NORMAL. THERE WERE NO ABNORMALITIES WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE NOR OBSERVED DURING PREPARATION. THE DEVICE WAS NOT RESTERILIZED. THE DEVICE WAS INSERTED DIRECTLY INTO THE SHEATH INTRODUCER. THE LESION WAS NOT CALCIFIED. THERE WAS NO PRESENCE OF TORTUOSITY NOR ANGULATION. THERE WAS NO STENOSIS. THE DEVICE WAS NOT USED FOR CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION> 3 MONTHS) AS THE VESSEL IS HEALTHY WITHOUT ANY INJURY OR OCCLUSION. THERE WAS NO RESISTANCE ENCOUNTERED WHEN REMOVING THE DEVICE. THE DEVICE DETACHED FROM THE MANIPULATION AREA CLOSE TO THE INTRODUCER. THE DOCTOR DID NOT SLAP THE BROKEN END. THE GUIDEWIRE USED IN THE PROCEDURE WAS NON-CORDIS. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9880245 ↗