TEMPO 451542V0Recalls & reported problems
Cordis Corporation · CATH TEMPO 5F C1 65CM · 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 10705032008648), received between Nov 16, 2020 and Nov 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.
MalfunctionNov 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, THE 5F 65CM TEMPO COBRA - CHILD 1 (C1) CATHETER WAS PARTIALLY BROKEN IN 2 PLACES DURING ITS REMOVAL. THE DISTAL BREAKAGE WAS COMPLETED DURING WASHING OF THE PHYSICIAN. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS OPENED IN STERILE FILED. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10846407 ↗
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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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