TEMPO AQUA 452413H0Recalls & reported problems
Cordis Corporation · CATH TEMPO AQUA 4F BER 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 20705032008836), received between Nov 25, 2019 and Nov 25, 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 18, 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.
InjuryNov 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
AFTER USE OF A CORDIS 4F 100CM BER TEMPO AQUA CATHETER FOR AN ANGIOGRAM INSIDE A PREVIOUSLY PLACED NON-CORDIS ABDOMINAL AORTIC ANEURYSM (AAA) GRAFT, THE CATHETER TIP LODGED BETWEEN THE NON-COVERED STRUTS OF THE AAA GRAFT. THE PHYSICIAN INSERTED A NON-CORDIS WIRE INTO THE TEMPO CATHETER BUT ONLY THE SHAFT OFF THE CATHETER CAME OUT AND THE TIP (APPROX. 3CM IN LENGTH) REMAINED INSIDE PATIENT. HE TRIED FOR SEVERAL HOURS TO REMOVE THE CATHETER TIP BUT WAS UNSUCCESSFUL. THE PATIENT WAS LATER BROUGHT BACK TO INTERVENTIONAL RADIOLOGY AND HAD THE TIP SUCCESSFULLY REMOVED. THE STATUS OF THE PATIENT WAS ¿SAFE¿. THE DEVICE WILL NOT BE RETURNED. NO PROCEDURAL CD WILL BE AVAILABLE FOR REVIEW. THE DEVICE WAS NOT INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTATIC VALVE. EXCESSIVE TORQUING WAS REQUIRED AGAINST THE AAA GRAFT. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THERE WAS NO RESISTANCE MET WHILE WITHDRAWING THE DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9369371 ↗
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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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