TEMPO 451431H0Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705032007948), received between Jul 28, 2020 and Jan 30, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Leak/Splash

  AS REPORTED, THE HUB OF A 4F SIM 2 100CM TEMPO DIAGNOSTIC CATHETER WAS LEAKING. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS A MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION. THE LEAK WAS IDENTIFIED AT THE HUB WHERE THE CATHETER CONNECTS TO THE LUER END AND WAS NOTICED WHEN ATTEMPTING TO PERFORM A HAND INJECTION. A CONTRALATERAL APPROACH WAS NOT USED. THE ACCESS SITE VESSEL WAS DESCRIBED AS NORMAL. THE DEVICE WAS FLUSHED PRIOR TO USE, AND THE SHEATH DILATOR WAS SECURELY CONNECTED AT THE HUB. NO DIFFICULTIES WERE ENCOUNTERED DURING INSERTION OR WITHDRAWAL. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE. NO DEVICE DAMAGE WAS NOTED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. NO UNUSUAL FORCE WAS USED DURING THE PROCEDURE, AND NO DIFFICULTIES WERE ENCOUNTERED WHILE INSERTING OR WITHDRAWING ANY CONCOMITANT DEVICES. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223292 ↗
• MalfunctionNov 27, 2024Leak/Splash; Leak/Splash

  AS REPORTED, WHEN USING A 4F 100CM SIDEWINDER SIMMONS 2 (SIM2) TEMPO DIAGNOSTIC CATHETER TO PERFORM AN ANGIOGRAM IN THE SUPERFICIAL FEMORAL ARTERY (SFA), THE DEVICE WAS CONNECTED TO AN UNKNOWN Y-VALVE AND LIQUID LEAKAGE WAS FOUND AT THE CONNECTION. THIS ¿TRIGGERED EXTRAVASATION OF THE CONTRAST AGENT WHEN IT WAS INJECTED INTO THE CONTRAST MEDIUM¿ WITH A HIGH-PRESSURE CONTRAST INJECTOR, WHICH AFFECTED THE QUALITY OF THE IMAGE. ADDITIONALLY, LARGE AMOUNTS OF LIQUID SEEPAGE WERE OBSERVED, AFFECTING THE ASEPTIC ENVIRONMENT. EXTRAVASATION, DEFINED AS A LEAKAGE OF A SOLUTION OUT OF THE VESSEL AND INTO THE SURROUNDING TISSUE OF THE PATIENT, DID NOT OCCUR. HOWEVER, THE TERM ¿EXTRAVASATION¿ WAS USED TO DESCRIBE AN EXCESS LEAKAGE OF CONTRAST SOLUTION COMING FROM THE LUER HUB CONNECTION, OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED BY CHANGING TO A NEW UNKNOWN CATHETER. THERE WERE NO REPORTED INJURIES TO THE PATIENT AND THE PATIENT WAS IN GOOD STATUS POST-PROCEDURE. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE LUER HUB OF THE 4F SIM2 TEMPO CATHETER, AND THERE WAS NO DIFFICULTY CONNECTING THE Y-VALVE TO THE LUER HUB OF THE 4F SIM2 TEMPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20795557 ↗
• MalfunctionApr 8, 2024Crack; Crack

  AS REPORTED, A 4F 100CM TEMPO CATHETER SIDEWINDER II (SIM 2) CATHETER WAS OBSERVED FRACTURED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19059548 ↗
• InjuryJul 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE 4F 100CM TEMPO CATHETER WENT OFF AND HAD TO BE REMOVED WITH THE HELP OF A VASCULAR SURGEON. THE MALFUNCTION OCCURRED DURING A NORMAL ANGIO PROCEDURE. THE DEVICE WAS STORED PER LABELLING AND OPENED IN STERILE FIELD. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PACKAGE. THE INTEGRITY OF THE STERILE POUCH WAS NOT COMPROMISED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Foreign Body In Patient

  MAUDE report 10332895 ↗