TEMPO 451403V5Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705032007719), received between Feb 8, 2019 and Aug 11, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (4 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2025Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  AS REPORTED, THE HEAD OF A 4F 65CM TEMPO DIAGNOSTIC CATHETER (PIGTAIL, 5 SIDE HOLES) WAS CUT DURING THE PROCEDURE ON AN AORTIC ENDOPROSTHESIS. THERE WAS AN INCIDENCE OF ILIAC DISSECTION UPON REMOVAL OF THE PROBE. ADDITIONALLY, A 5F 110CM TEMPO DIAGNOSTIC CATHETER (UNIVERSAL FLUSH, 5 SIDE HOLES) SHOWED BLUE PARTICLES DURING HANDLING IN THE PROCEDURE; IT APPEARED THAT THE REINFORCEMENT AT THE END OF THE CATHETER HAD DISLOCATED AND NOTHING REMAINS. THERE WAS NO ADDITIONAL REPORTED PATIENT INJURY. THE ISSUE REPORTEDLY INVOLVED THE CATHETER AND THE GUIDEWIRE, AS WELL AS THE PATIENT¿S CONDITION. THE PROCEDURE WAS MORE BURDENSOME FOR THE PATIENT, REQUIRING MORE EQUIPMENT. THE PATIENT AND HER SISTER WERE INFORMED, AND THE ISSUE WAS NOTED IN THE "CRO" RECORDS. THE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22777887 ↗
• MalfunctionOct 21, 2022Crack; Crack

  AS REPORTED, THE UPPER PART OF 4F PIGTAIL 5 SIDE HOLES (SH) TEMPO CATHETER WAS OBSERVED TO BE FRACTURE AND DOES NOT ALLOW THE PROPER USE OF THIS "INPUT". THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE WAS A DIAGNOSTIC TEST. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15653636 ↗
• InjuryApr 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 4F TEMPO PIG 65CM 5SH DIAGNOSTIC CATHETER WAS MOVING OVER THE WIRE AND THE WIRE COATING GOT DISSOLVED IN FRONT OF THE CATHETER, THE MATERIAL WAS PUSHED INTO THE PERIPHERY OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8491694 ↗
• MalfunctionFeb 8, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, AFTER FLUSHING THE DOCTOR BRING THE WIRE INTO THE TIP OF THE PIG TEMPO DIAGNOSTIC CATHETER AND THEN, THE PHYSICIAN NOTICED AN UNDEFINABLE JELLYLIKE LIQUID. THERE WAS NO REPORTED PATIENT INJURY. THE SAME HAPPEN WITH FOUR (4) CATHETERS FROM THE SAME LOT NUMBER. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THERE WAS EXCESSIVE FORCE APPLIED TO THE DEVICE DURING WITHDRAWAL FROM PACKAGE. NEITHER THE PRODUCT NOR ANY OF THE OTHER DEVICES USED WERE RESTERILIZED. THE INTEGRITY OF THE STERILE POUCH WAS COMPROMISED. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREP NORMALLY. THERE WERE NO ANOMALIES NOTED DURING OR AFTER THE DEVICE WAS PREPPED. THE ACTUAL PRODUCT WAS NOT DAMAGED. THE DEVICES WERE NOT USED ON PATIENT. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS AS A RESULT OF THE FAILURE WITH THE DEVICE. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8320086 ↗
• MalfunctionFeb 8, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, AFTER FLUSHING THE DOCTOR BRING THE WIRE INTO THE TIP OF THE PIG TEMPO DIAGNOSTIC CATHETER AND THEN, THE PHYSICIAN NOTICED AN UNDEFINABLE JELLYLIKE LIQUID. THERE WAS NO REPORTED PATIENT INJURY. THE SAME HAPPEN WITH FOUR (4) CATHETERS FROM THE SAME LOT NUMBER. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THERE WAS EXCESSIVE FORCE APPLIED TO THE DEVICE DURING WITHDRAWAL FROM PACKAGE. NEITHER THE PRODUCT NOR ANY OF THE OTHER DEVICES USED WERE RESTERILIZED. THE INTEGRITY OF THE STERILE POUCH WAS COMPROMISED. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREP NORMALLY. THERE WERE NO ANOMALIES NOTED DURING OR AFTER THE DEVICE WAS PREPPED. THE ACTUAL PRODUCT WAS NOT DAMAGED. THE DEVICES WERE NOT USED ON PATIENT. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS AS A RESULT OF THE FAILURE WITH THE DEVICE. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8320062 ↗
• MalfunctionFeb 8, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, AFTER FLUSHING THE DOCTOR BRING THE WIRE INTO THE TIP OF THE PIG TEMPO DIAGNOSTIC CATHETER AND THEN, THE PHYSICIAN NOTICED AN UNDEFINABLE JELLYLIKE LIQUID. THERE WAS NO REPORTED PATIENT INJURY. THE SAME HAPPEN WITH FOUR (4) CATHETERS FROM THE SAME LOT NUMBER. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THERE WAS EXCESSIVE FORCE APPLIED TO THE DEVICE DURING WITHDRAWAL FROM PACKAGE. NEITHER THE PRODUCT NOR ANY OF THE OTHER DEVICES USED WERE RESTERILIZED. THE INTEGRITY OF THE STERILE POUCH WAS COMPROMISED. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREP NORMALLY. THERE WERE NO ANOMALIES NOTED DURING OR AFTER THE DEVICE WAS PREPPED. THE ACTUAL PRODUCT WAS NOT DAMAGED. THE DEVICES WERE NOT USED ON PATIENT. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS AS A RESULT OF THE FAILURE WITH THE DEVICE. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8320027 ↗
• MalfunctionFeb 8, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, AFTER FLUSHING THE DOCTOR BRING THE WIRE INTO THE TIP OF THE PIG TEMPO DIAGNOSTIC CATHETER AND THEN, THE PHYSICIAN NOTICED AN UNDEFINABLE JELLYLIKE LIQUID. THERE WAS NO REPORTED PATIENT INJURY. THE SAME HAPPEN WITH FOUR (4) CATHETERS FROM THE SAME LOT NUMBER. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THERE WAS EXCESSIVE FORCE APPLIED TO THE DEVICE DURING WITHDRAWAL FROM PACKAGE. NEITHER THE PRODUCT NOR ANY OF THE OTHER DEVICES USED WERE RESTERILIZED. THE INTEGRITY OF THE STERILE POUCH WAS COMPROMISED. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREP NORMALLY. THERE WERE NO ANOMALIES NOTED DURING OR AFTER THE DEVICE WAS PREPPED. THE ACTUAL PRODUCT WAS NOT DAMAGED. THE DEVICES WERE NOT USED ON PATIENT. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS AS A RESULT OF THE FAILURE WITH THE DEVICE. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8320005 ↗