TEMPO 451442V2Recalls & reported problems
Cordis Corporation · CATH TEMPO 4F C1 65CM 2SH · 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 10705032008037), received between Feb 9, 2026 and Feb 9, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (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.
Reports received per month
Most reported problems
Device problems
- Crack1
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.
MalfunctionFeb 9, 2026Crack
AS REPORTED, THE CAP AT THE TOP OF A 4F COBRA (C) 1 65CM TEMPO DIAGNOSTIC CATHETER WAS BROKEN WHEN A SYRINGE WAS ATTACHED, WHICH CAUSED LEAKING. THERE WAS NO REPORTED PATIENT INJURY. AS FAR AS THE OPERATOR IS AWARE, THERE WAS NOT ANY EXCESS PRESSURE USED WHICH COULD HAVE CAUSED THE ISSUE. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WAS NOT RETURNED AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24293829 ↗
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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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