INFINITI 538445Recalls & reported problems
Cordis US Corp. · CATH F4 INF AL I 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032014762), received between Apr 4, 2022 and Apr 4, 2022 — classified as 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Cramp(s) /Muscle Spasm(s)1
- Vasoconstriction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 4, 2022Detachment of Device or Device Component
AS REPORTED, THE SMALL ATRAUMATIC BLUNT TIP OF THE INFINITI CORONARY ANGIOGRAPHY CATHETER (CATH F4 INF AL I 100CM) SEPARATED FROM THE ¿PROBE¿ DURING WITHDRAWAL OF THE "PROBE" DUE TO RADIAL SPASM. THERE WAS NO REPORTED PATIENT INJURY. BOTH THE CATHETER AND THE TIP WERE REMOVED FROM THE PATIENT. THE INTENDED PROCEDURE WAS REPORTED TO BE A DIAGNOSTIC CORONAROGRAPHY AND THE ACCESS SITE WAS RADIAL. 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 (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. IT IS UNKNOWN IF THERE WAS RESISTANCE MET WHILE ADVANCING THE DEVICE AND OR IF THERE WAS RESISTANCE/FRICTION EXPERIENCED DURING ANY PART OF THE PROCEDURE. IT IS ALSO UNKNOWN IF UNUSUAL FORCE WAS NECESSARY DURING THE USE OF THE DEVICE OR IF EXCESSIVE TORQUING WAS REQUIRED. THE ATRAUMATIC END IN THE DISTAL PART TIP SEPARATED. THE TIP WAS RECOVERED AT THE SAME TIME AS THE CATHETER WAS REMOVED. THERE WAS NO CONSEQUENCE TO THE PATIENT AS A RESULT OF THE REMOVAL; HOWEVER, THE PATIENT EXPERIENCED RADIAL SPASM. IT IS UNKNOWN IF THE PATIENT WAS HOSPITALIZED OR IF THE P
Patient problems: Cramp(s) /Muscle Spasm(s); Vasoconstriction
MAUDE report 13995879 ↗
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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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