INFINITI 538418Recalls & reported problems
Cordis Corporation · CATH F4 INF JL 3.5 100CM · Class 2
All models of INFINITI (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032014588), received between Apr 30, 2024 and Dec 11, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, A 4F INFINITI JUDKINS LEFT 3.5 100CM CORONARY DIAGNOSTIC CATHETER BROKE DURING CONTRAST INJECTION OUTSIDE THE PATIENT (DURING SYSTEM PURGING) AT THE START OF THE PROCEDURE. THE CATHETER RUPTURED IN TWO PARTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNKNOWN CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20906437 ↗InjuryApr 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DISCONNECTION OF THE INFINITI F4 JL3.5 TIP FROM THE REST OF THE MEDICAL DEVICE, RESULTING IN EMBOLIZATION IN THE DISTAL CIRCUMFLEX ARTERY. THE EMBOLIZATION WAS PERFORMED IN THE "CORRECT DIRECTION", WITHOUT BLOCKING BLOOD FLOW. THE ENDOTHELIALIZATION PROCESS SHOULD THE TIP, BUT THE RISK OF MYOCARDIAL INFARCTION (MI) IS NOT NEGLIGIBLE. THE TIP HAS NOT BEEN REMOVED. THE RISK/BENEFIT RATIO OF TIP REMOVAL IS POOR. IN FACT, ITS RECOVERY COULD DISPLACE IT. NO IMMEDIATE CONSEQUENCES TO THE PATIENT, BUT POSSIBILITY OF MI OR STROKE IF TIP MIGRATES. THE PATIENT WAS PLACED ON LONG TERM MEDICINE THERAPY. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19214597 ↗
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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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