TEMPO 451503V5Recalls & reported problems
Cordis Corporation · CATH TEMPO 5F PIG 65CM 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 10705032008297), received between Mar 15, 2021 and Mar 15, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 15, 2021Difficult to Remove; Difficult to Remove
AS REPORTED, THEY TWISTED WHEN REMOVING THE 5F 65CM 5 SIDE HOLES (SH) TEMPO PIGTAIL ANGIOGRAPHIC CATHETER AND WAS VERY DIFFICULT TO REMOVE. THE CATHETER WAS TWISTED DURING MANIPULATION. THE CATHETER WAS NOTED TO BE KINKED/FOLDED AT THE TIME OF THE "TWIST" OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY AND THE PATIENT RECOVERED. THE EVENT DID NOT RESULT IN A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE PROCEDURE; THE PROCEDURE WAS INCREASED BY LESS THAN 5 MINUTES. THE EVENT DID NOT CAUSE A CONDITION THAT REQUIRES HOSPITALIZATION OR A SIGNIFICANT EXTENSION OF AN EXISTING HOSPITALIZATION. THE USER WAS VERY EXPERIENCED WITH THE DEVICE AND THE PROCEDURE. A PIGTAIL CATHETER WAS USED ON AN UNKNOWN AORTIC STENT GRAFT. THE TARGET VESSEL WAS THE AORTA WITH RIGHT FEMORAL ACCESS WITH IPSILATERAL APPROACH. THERE WAS NO VESSEL CALCIFICATION, TORTUOSITY, STENOSIS, ANGULATION, OR BIFURCATION AT THE TARGET SITE NOR AT THE ACCESS SITE. THE DEVICE WAS NOT USED FOR A CTO. THERE WAS NO PROBLEM SETTING UP. THE DEVICE HAS BEEN STORED AND PREPARED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DIFFICULTIES IN THE PREPARATION OF THE DEVICE. THE OTHER DEVICES USED WITH THE PR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11483290 ↗
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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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