INFINITI 538448Recalls & reported problems
Cordis US Corp. · CATH F4 INF AR MOD 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 10705032014793), received between Jun 3, 2021 and Jun 3, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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
- Material Fragmentation1
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.
MalfunctionJun 3, 2021Material Fragmentation; Material Fragmentation
DURING A DIAGNOSTIC PROCEDURE, THE STRAIN RELIEF OF A 4F 100CM AMPLATZ RIGHT I (AR1) MODIFIED (MOD) INFINITI CATHETER APPEARED TO ¿DEGRADE AND FRAGMENT¿ WHILE THE CATHETER WAS BEING POSITIONED IN PLACE. IT WAS ALSO NOTED TO HAVE A SLIGHT LEAK IN THE FUSING JOINT BETWEEN THE CATHETER AND THE HUB. THEREFORE, THE INFINITI CATHETER WAS REMOVED AND SET ASIDE, AND ANOTHER UNKNOWN CATHETER WAS USED TO COMPLETE THE CASE. THE CATHETER WAS INSPECTED, EXCEPT FOR THE HUB AND THE REST OF THE CATHETER WAS INTACT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION. DEVICE IMAGES ARE AVAILABLE FOR REVIEW. THE DEVICE WAS STORED IN A CLIMATE CONTROLLED (MANNER) IN THE CATH LAB. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THE DEVICE WAS NOT RESTERILIZED. THE DEVICE WAS PULLED FROM THE PACKAGING BY THE HUB BUT NO ANOMALIES WERE NOTED. THE DEVICE WAS PREPPED FOLLOWING IFU INSTRUCTIONS. A 4F CORDIS FEMORAL CATHETER SHEATH INTRODUCER WAS USED WITH A NON-CORDIS .035¿ GUIDEWIRE. THERE WAS NO EXCESSIVE FORCE USED AT ANY TIME WHILE HANDLING THE DEVICE. THE DEVICE WAS USED IN THE PATIENT AND WAS TORQUED OR ¿STEERED¿ BY THE HUB. THE DEVICE WAS NOT E
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11931492 ↗
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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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