INFINITI 538493Recalls & reported problems
Cordis Corporation · CATH MPAC INF 4F JR4/JL4/PIG · Class 2
All models of INFINITI (22)
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 10705032014953), received between Mar 28, 2024 and Mar 28, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
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 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, A 4F INFINITI DIAGNOSTIC CATHETER SEPARATED IN TWO PIECES. THE DEVICE WAS BROKEN NEAR THE HUB. THE BROKEN SEGMENT WAS STILL OUTSIDE THE PATIENT AND WAS RETRIEVED. THE ENTIRE PRODUCT WAS ABLE TO BE REMOVED WITH NOTHING LEFT BEHIND. ANOTHER INFINITI CATHETER WAS USED TO GET THE DIAGNOSTIC HEART CATHETERIZATION PROCEDURE COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. IT WAS DURING THE SECOND INJECTION. A 4F NON-CORDIS SHEATH WAS USED. THERE WERE NO ANOMALIES NOTED WHEN THE PRODUCT WAS REMOVED FROM THE PACKAGE. THE PRODUCT WAS STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (FU). THE TARGET LESION WAS REPORTED TO BE THE LEFT MAIN CORONARY ARTERY (LCA). LESION CALCIFICATION IS UNKNOWN; THERE WAS NO VESSEL TORTUOSITY AND THE PERCENTAGE STENOSIS IS UNKNOWN. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO UNUSUAL FORCE NECESSARY DURING USE OF THE DEVICE AND NO RESISTANCE/ FRICTION EXPERIENCED DURING ANY PART OF THE PROCEDURE. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE. EXCESSIVE TORQUING WAS NOT REQUIRED. THE TIP WAS VISIBLE ON FLUOROSCOPY THROUGHOUT THE PROCEDURE. THE DEVICE WAS RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18992822 ↗
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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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