TEMPO 451504L5Recalls & reported problems
Cordis Corporation · CATH TEMPO 5F UF 110CM 5SH · Class 2
All models of TEMPO (56)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032008310), received between Aug 11, 2025 and Aug 11, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Degraded” (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.
Reports received per month
Most reported problems
Device problems
- Degraded1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2025Degraded; Degraded
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 WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22779738 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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