TEMPO SRD5601Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032063095), received between Oct 10, 2019 and Dec 23, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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.

• MalfunctionDec 23, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, IT WAS FOUND THAT THERE WAS A WHITE POWDERY FOREIGN MATERIAL IN THE PACKAGING OF 5F .038 80CM TEMPO DIAGNOSTIC CATHETER. THE HOSPITAL HAD CONFIRMED, THE OUTER PACKAGING WAS BROKEN. THE DEVICE COULD NOT BE USED FOR THE PATIENT DUE TO THIS ISSUE. TO COMPLETE THE PROCEDURE, ANOTHER ANGIOGRAPHIC CATHETER WAS USED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9513252 ↗
• InjuryOct 10, 2019Difficult to Remove; Difficult to Remove

  AS REPORTED, THERE WAS DIFFICULTY WITHDRAWING THE 5F TEMPO .038 80CM HEPATIC ANGIOGRAPHIC CATHETER AND THE CATHETER WAS KINKED DURING REMOVAL. THE FEMORAL ARTERY WAS CUT IN ORDER TO REMOVE THE TEMPO CATHETER AND AS A RESULT THE FOOT PULSE WAS WEEK AND THROMBUS WAS FORMED WHICH HAD TO BE REMOVED. SEVERAL ATTEMPTS WERE MADE TO REMOVE THE TEMPO CATHETER AND IT STILL COULD NOT BE REMOVED. IT WAS ADVISED TO CUT RIGHT FEMORAL ARTERY TO REMOVE THE CATHETER MAINTAINING INSIDE THE ILIAC ARTERY. THE CATHETER INSIDE THE ILIAC ARTERY WAS REMOVED SUCCESSFULLY BY CUTTING THE FEMORAL ARTERY. IT WAS NOTICED THAT THE FOOT PULSES WERE WEEK AFTER REMOVAL OF CATHETER. CONSIDERING THAT THE ARTERIAL SHEATH BEING PLACED FOR A LONG TIME WILL FORM THE THROMBUS, THE ANGIOGRAPHIC CATHETER WAS INSERTED INTO RIGHT ILIAC ARTERY FROM LEFT FEMORAL ARTERY. THE ANGIOGRAPHIC EXAMINATION SHOWED THAT THE INFLATION OF THE SUTURE SEGMENT OF THE RIGHT FEMORAL WAS DEFECTED, AND THE BLOOD FLOW OF THE DISTAL SEGMENT OF THE RIGHT LOWER LIMB ARTERY WAS SLOW. THE THROMBUS WAS REMOVED BY HEMOSTATIC FORCEPS AFTER REMOVING THE ORIGINAL GAP SEAM OF THE RIGHT FEMORAL ARTERY, BUT EJECTING BLOOD, SO SUTURING THE GAP OF THE RIGHT FEMO

  Patient problems: Thrombosis

  MAUDE report 9176933 ↗