INFINITI 538455SRecalls & reported problems
Cordis US Corp. · CATH4F INF PIG 155° MOD 110CM · Class 2
All models of INFINITI (20)
Data updated Oct 18, 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 10705032014854), received between Apr 3, 2019 and Apr 3, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (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
- Material Puncture/Hole1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2019Material Puncture/Hole; Material Puncture/Hole
AS REPORTED, A NON-CORDIS GUIDEWIRE HAD GONE THROUGH THE NECK OF AN INFINITI DIAGNOSTIC CATHETER (CATH4F INF PIG 155 DEGREE MOD 110CM) LEAVING THE CATHETER TIP EXPOSED INSIDE THE PATIENT WITHOUT A WIRE. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS. THE SHEATH THAT WAS RETURNED WITH THE DIAGNOSTIC CATHETER AND GUIDEWIRE WAS A NON-CORDIS DEVICE. THERE WERE NO ANOMALIES NOTED TO THE DEVICE PACKAGING. THERE WAS NO DAMAGE NOTED TO THE DEVICE WHEN REMOVED FROM THE PACKAGING. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED PER THE IFU. THERE WAS NO RESISTANCE/FRICTION NOTED WHEN INSERTING THE DEVICE INTO THE PATIENT. NO EXCESSIVE FORCE WAS USED AT ANY TIME DURING THE PROCEDURE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8479238 ↗
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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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