TEMPO 451401L5Recalls & reported problems
Cordis Corporation · CATH TEMPO 4F STR 110CM 5SH · Class 2
Data updated Oct 13, 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 10705032007634), received between Jun 16, 2020 and Jun 16, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- 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.
MalfunctionJun 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, THE 4F STRAIGHT (STR) 65CM 5 SIDE HOLES (SH) TEMPO DIAGNOSTIC CATHETER WAS INSERTED OVER A NON-CORDIS GUIDEWIRE (GW) INTO THE LUMEN; INSERTION HAS BEEN DESCRIBED AS VERY SMOOTH, HOWEVER, WHEN ANGIOGRAM WAS PERFORMED, A FOREIGN BODY WAS DETECTED IN THE TIBIAL-FIBULAR TRUNK. THEREFORE, AN UNKNOWN 4F CATHETER SHEATH INTRODUCER (CSI) WAS EXCHANGED FOR AN UNKNOWN 5F CSI TO FACILITATE THE USE OF A SNARE TO RETRIEVE THE FOREIGN BODY, WHICH HAS BEEN CONDUCTED SUCCESSFULLY. OUTSIDE THE PATIENT¿S, IT COULD BE CLEARLY SEEN, THAT THE FOREIGN BODY WAS THE TIP (CA. 3CM OF THE DISTAL END) OF THE TEMPO DIAGNOSTIC CATHETER. IT WAS REPORTED THAT THE EDGE WAS VERY SHARP AND LOOKED LIKE IT WAS CUT BY A SCALPEL. PROCEDURE WAS COMPLETED SUCCESSFULLY. COMPLAINT DID NOT CAUSE ANY PATIENT INJURY. NO PROLONGED HOSPITAL STAY. THE PATIENT RECOVERED THE INTENDED PROCEDURE WAS FOR A LEFT LOWER EXTREMITY (STENOSIS IN POSTERIOR TIBIAL ARTERY). THE TARGET LESION WAS POSTERIOR TIBIAL ARTERY. THE LESION WAS SEVERELY CALCIFIED. THERE WAS NO VESSEL TORTUOSITY. THERE WAS LITTLE VESSEL ANGULATION. THERE WAS 70% OF STENOSIS. THE TARGET SITE WAS NOT BIFURCATING, MILD POSTERIOR TIBIAL ARTERY. THE DEVICE WAS NO
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10157563 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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