TEMPO SRD5821Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032049146), received between Oct 6, 2020 and Jan 10, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionJan 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  AS REPORTED, THE CONNECTION BETWEEN A 4F 0.038IN X 65CM VERTEBRAL TEMPO DIAGNOSTIC CATHETER AND A SYRINGE WAS IMPOSSIBLE. THIS ATTEMPT WAS MADE IN ORDER TO FLUSH THE DEVICE. THE TEMPO CATHETER WAS REPLACED WITH ANOTHER UNKNOWN TEMPO CATHETER. THERE WERE NO REPORTS OF PATIENT INJURY. IT IS UNKNOWN IF THE PATIENT HAD AN INFECTION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, AS IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16130426 ↗
• MalfunctionOct 6, 2020Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, A 4F 65CM 0.038¿ TEMPO CATHETER WAS INSERTED, AND TWO NON-CORDIS INTERLOCKS WERE IMPLANTED. HOWEVER, THERE WAS AN INTENSIVE RESISTANCE FELT WHEN IT WAS RELEASED. THE PHYSICIAN NOTICED THAT THE JUNCTION BETWEEN THE TIP AND THE CATHETER WAS SPLIT. SOME TORNADO COILS WERE IMPLANTED, AND THE INTERLOCKS WERE INSERTED AGAIN. THE PHYSICIAN ATTEMPTED TO IMPLANT IT, BUT IT WAS NOT ABLE TO DETACH. THEY WERE REMOVED AND REPLACED WITH OTHER NON-CORDIS INTERLOCK, BUT THE SAME ISSUE OCCURRED AGAIN. IT WAS IMPLANTED BUT THERE WERE ABNORMALITIES WHEN IT WAS DETACHED. AFTER COIL EMBOLIZATION, THE TEMPO CATHETER WAS REMOVED FROM THE 5F NON-CORDIS SHEATH INTRODUCER. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE LEFT SUBCLAVIAN ARTERY. THE PROCEDURE WAS A COIL EMBOLIZATION. A 6F NON-CORDIS SHEATH INTRODUCER, A NON-CORDIS 0.035 INCHES 180 CM GUIDEWIRE, A NON-CORDIS INTERLOCK COIL AND A NON-CORDIS TORNADO COIL WERE USED TOGETHER. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10636077 ↗