TEMPO 451535H0Recalls & reported problems
Cordis Corporation · CATH TEMPO 5F H1 100CM · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032008624), received between Apr 29, 2019 and Apr 29, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Crack” (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
Device problems
- Crack1
- Detachment of Device or Device Component1
Patient problems
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 29, 2019Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component
AS REPORTED, THE 5F TEMPO DIAGNOSTIC CATHETER WAS FRACTURED IN THE PATIENT. THE DEVICE WAS REMOVED SUCCESSFULLY FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE CURRENT STATUS OF THE PATIENT IS GREAT. THE LESION CHARACTERISTICS WAS THE ACUTE POSTERIOR CIRCULATION INFARCTION. THE TARGET LESION WAS THE LEFT VERTEBRAL ARTERY OCCLUSION. THE VESSEL LEVEL OF CALCIFICATION AND TORTUOSITY IS SEVERE. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED PER THE IFU. THE CATHETER WAS NOT RE-SHAPED BY THE USER. THERE WERE NO ANOMALIES NOTED DURING OR AFTER THE DEVICE WAS PREPPED. THE CATHETER WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO INSERTION INTO THE PATIENT. THE CATHETER TIP WAS VISIBLE ON FLUORO THROUGHOUT THE PROCEDURE. THERE WAS DIFFICULTY TRACKING THE CATHETER THROUGH THE VESSEL OR LESION. THE CATHETER WAS TORQUED AGAINST RESISTANCE. THE FRONT SEGMENT OF THE CATHETER WAS FRACTURED INSIDE THE PATIENT. THERE WERE KINK/BENT NOTED AFTER DEVICE WAS REMOVED FROM PATIENT. THERE IS NO PROCEDURAL FILM/CD AVAILABLE FOR REVIEW. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE DEVICE WAS RECEIVED IN TWO PIECES.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 8560557 ↗
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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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