TEMPO 451515H0Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705032008471), received between Mar 25, 2019 and Dec 10, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Crack” (3 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.

• MalfunctionDec 10, 2025Degraded; Degraded

  AS REPORTED, THE BLUE COVER OF TWO 5F PITGTAIL 90CM 5 SIDE HOLES AND ONE 5F BERENSTEIN II 100CM TEMPO DIAGNOSTIC CATHETERS WERE PEELING. THERE WAS NO REPORTED PATIENT INJURY AS THEY WERE NOT USED ON A PATIENT. THE DEVICES WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767804 ↗
• MalfunctionApr 5, 2019Crack; Crack

  AS REPORTED, A QUANTITY OF THREE 5F TEMPO BER II 100CM DIAGNOSTIC CATHETERS WERE BEING USED FOR A THORACIC ENDOVASCULAR ANEURYSM REPAIR (TEVAR), THE FIRST CATHETER WAS FOUND TO BE LEAKING WHEN BEING FLUSHED AND THE OTHER TWO BROKE WHEN BEING PUT ON THE WIRE. THERE WAS NO REPORTED PATIENT INJURY. THE SECOND AND THIRD CATHETERS WERE NOT USED INSIDE THE PATIENT. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. AT THE TIME ALL OF THE CATHETERS WERE IN DATE, A FEW WERE ABOUT TO EXPIRE. ANOTHER CORDIS 5F TEMPO BER 100CM CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ANOMALIES WERE NOTED WHEN THE FIRST DEVICE WAS REMOVED FROM THE PACKAGING. THE FIRST DEVICE WAS NOT RESTERILIZED. THE FIRST DEVICE WAS FLUSHED WITH HEPARINIZED SALINE FOR THE INSERTION OF THE GUIDEWIRE. UPON FLUSHING THE FIRST DEVICE, IT WAS NOTICED THAT THERE WAS A CLEAN BREAK MID-SHAFT OF THE CATHETER. THE SECOND DEVICE WAS REMOVED FROM THE PACKAGING AND WAS FLEXED TO MAKE SURE IT WAS STRONG, IT SNAPPED IN FOUR PLACES. NO FURTHER ANOMALIES WERE NOTED DURING PREP OF THE SECOND DEVICE. THE SECOND DEVICE WAS DISCARDED. THE THIRD DEVICE WAS REMOVED FROM THE PACKAGING AND WAS FLEXED TO MAKE SURE IT WAS STRONG, IT SNAPPED IN F

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8488704 ↗
• MalfunctionApr 5, 2019Crack; Crack

  AS REPORTED, A QUANTITY OF THREE 5F TEMPO BER II 100CM DIAGNOSTIC CATHETERS WERE BEING USED FOR A THORACIC ENDOVASCULAR ANEURYSM REPAIR (TEVAR), THE FIRST CATHETER WAS FOUND TO BE LEAKING WHEN BEING FLUSHED AND THE OTHER TWO BROKE WHEN BEING PUT ON THE WIRE. THERE WAS NO REPORTED PATIENT INJURY. THE SECOND AND THIRD CATHETERS WERE NOT USED INSIDE THE PATIENT. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. AT THE TIME ALL OF THE CATHETERS WERE IN DATE, A FEW WERE ABOUT TO EXPIRE. ANOTHER CORDIS 5F TEMPO BER 100CM CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ANOMALIES WERE NOTED WHEN THE FIRST DEVICE WAS REMOVED FROM THE PACKAGING. THE FIRST DEVICE WAS NOT RESTERILIZED. THE FIRST DEVICE WAS FLUSHED WITH HEPARINIZED SALINE FOR THE INSERTION OF THE GUIDEWIRE. UPON FLUSHING THE FIRST DEVICE, IT WAS NOTICED THAT THERE WAS A CLEAN BREAK MID-SHAFT OF THE CATHETER. THE SECOND DEVICE WAS REMOVED FROM THE PACKAGING AND WAS FLEXED TO MAKE SURE IT WAS STRONG, IT SNAPPED IN FOUR PLACES. NO FURTHER ANOMALIES WERE NOTED DURING PREP OF THE SECOND DEVICE. THE SECOND DEVICE WAS DISCARDED. THE THIRD DEVICE WAS REMOVED FROM THE PACKAGING AND WAS FLEXED TO MAKE SURE IT WAS STRONG, IT SNAPPED IN F

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8488629 ↗
• MalfunctionMar 25, 2019Crack; Leak/Splash; Crack; Leak/Splash

  AS REPORTED, A QUANTITY OF THREE 5F TEMPO BER II 100CM DIAGNOSTIC CATHETERS WERE BEING USED FOR A THORACIC ENDOVASCULAR ANEURYSM REPAIR (TEVAR), THE FIRST CATHETER WAS FOUND TO BE LEAKING WHEN BEING FLUSHED AND THE OTHER TWO BROKE WHEN BEING PUT ON THE WIRE. THERE WAS NO REPORTED PATIENT INJURY. THE SECOND AND THIRD CATHETERS WERE NOT USED INSIDE THE PATIENT. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. AT THE TIME ALL OF THE CATHETERS WERE IN DATE, A FEW WERE ABOUT TO EXPIRE. ANOTHER CORDIS 5F TEMPO BER 100CM CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ANOMALIES WERE NOTED WHEN THE FIRST DEVICE WAS REMOVED FROM THE PACKAGING. THE FIRST DEVICE WAS NOT RESTERILIZED. THE FIRST DEVICE WAS FLUSHED WITH HEPARINIZED SALINE FOR THE INSERTION OF THE GUIDEWIRE. UPON FLUSHING THE FIRST DEVICE, IT WAS NOTICED THAT THERE WAS A CLEAN BREAK MID-SHAFT OF THE CATHETER. THE SECOND DEVICE WAS REMOVED FROM THE PACKAGING AND WAS FLEXED TO MAKE SURE IT WAS STRONG, IT SNAPPED IN FOUR PLACES. NO FURTHER ANOMALIES WERE NOTED DURING PREP OF THE SECOND DEVICE. THE SECOND DEVICE WAS DISCARDED. THE THIRD DEVICE WAS REMOVED FROM THE PACKAGING AND WAS FLEXED TO MAKE SURE IT WAS STRONG, IT SNAPPED IN F

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8448035 ↗