INFINITI 538472Recalls & reported problems
Cordis US Corp. · CATH F4 INF LCB 100CM · Class 2
All models of INFINITI (20)
Data updated Oct 16, 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 10705032014908), received between Aug 6, 2021 and Aug 6, 2021 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
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.
MalfunctionAug 6, 2021Crack; Crack
WHILE TORQUING AND ADVANCING A 4F 100CM LEFT CORONARY BYPASS (LCD) (B)(6) DIAGNOSTIC CATHETER, THE STRAIN RELIEF CRACKED, AND THE BODY OF THE CATHETER KINKED. THEREFORE, THE DEVICE WAS REMOVED, AND ANOTHER UNKNOWN CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS PERFORMED ON THE RETURNED DEVICE ALSO SHOWED A TORN/SEPARATED AREA OF THE BODY/SHAFT. THE DEVICE WAS INTENDED TO BE USED IN A DIAGNOSTIC CATHETERIZATION PROCEDURE. OVER THE LAST 2 YEARS THIS CUSTOMER HAS BEEN USING A NEW TECHNOLOGY IN THEIR PROCEDURE ROOMS FOR CONTINUED STERILIZATION. IT USES UV LIGHT WHILE THE LABS AREN¿T IN USE WHICH IS ABOVE 54 DEGREES. DX & GUIDE CATHETERS ARE STORED IN CABINETS WITH GLASS FACES. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12289655 ↗
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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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