TEMPO AQUA 452531H0Recalls & reported problems
Cordis Corporation · CATH TEMPO AQUA 5F SIM 2 100CM · Class 2
All models of TEMPO AQUA (6)
Data updated Oct 18, 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 20705032009048), received between Apr 15, 2020 and Apr 15, 2020 — 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 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Difficult to Remove1
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.
InjuryApr 15, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
DURING A CEREBRAL ANGIOGRAPHY, THE PHYSICIAN USED A 5F 2 100CM TEMPO AQUA SIDEWINDER SIMMONS TECHNIQUE II (SIM2) ANGIOGRAPHIC CATHETER AND THE CATHETER BROKE INSIDE THE PATIENT. THERE WAS RESISTANCE MET WHILE ADVANCING THE DEVICE AND RESISTANCE MET WHILE WITHDRAWING THE DEVICE BECAUSE THE PATIENT HAD VERY TORTUOUS AND CALCIFIED ARTERIES AND THEREFORE IT WASN¿T EASY TO MOVE THE CATHETER. THE PHYSICIAN REMOVED THE LOST PIECE WITH A SNARE. THE PATIENT IS ALIVE. THE EVENT DID NOT CAUSE A CONDITION THAT REQUIRES HOSPITALIZATION OR SIGNIFICANT PROLONGATION OF EXISTING HOSPITALIZATION. THE EVENT DID NOT CAUSE A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE PROCEDURE. THERE WAS SEVERE CALCIFICATION OF THE LESION. THERE WAS MODERATE VESSEL TORTUOSITY. THE DEVICE WAS NOT RESTERILIZED. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THERE WERE NO ANOMALIES NOTED DURING PREP. THERE IS NO PROCEDURAL CD AVAILABLE FOR REVIEW. OTHER ADDITIONAL PATIENT/PROCEDURAL DETAILS WERE REQUESTED BUT WERE UNKNOWN. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9963797 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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