TEMPO 451406V0Recalls & reported problems
Cordis Corporation · CATH TEMPO 4F MP A1 (I) 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032007771), received between Jun 15, 2019 and Jun 15, 2019 — classified as 1 injury.
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
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, TWO TEMPO CATHETERS (CATH TEMPO 4F BER II 65CM, CATH TEMPO 4F MP A1 (I) 65CM, CATH TEMPO 4F BER II 65CM) BECAME SEPARATED WHILE BEING USED WITH A NON-CORDIS LIVER AND BIOPSY SET. THE SEPARATED SEGMENTS MIGRATED TO THE LUNG ARTERIES AND WERE SNARED/RETRIEVED USING AN UNKNOWN DEVICE. THE DEVICES WERE CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS. THREE DIFFERENT CORDIS PACKAGES WERE RETURNED WITH ONLY TWO CORDIS CATHETERS. IT IS UNKNOWN WHICH LOT CORRESPONDS WITH WHICH CATHETER. THE DEVICE DID NOT KINK IN THE AREA OF SEPARATION. THE DEVICE SEPARATED APPROXIMATELY 2.5CM AND 2.3CM FROM THE DISTAL END.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8702379 ↗
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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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