INFINITI 538422Recalls & reported problems
Cordis US Corp. · CATH F4 INF JL 5 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 10705032014625), received between Dec 7, 2021 and Dec 7, 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
- Material Puncture/Hole1
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.
MalfunctionDec 7, 2021Crack; Material Puncture/Hole; Crack; Material Puncture/Hole
AS REPORTED, A GUIDEWIRE WENT THROUGH THE CATH F4 INF JL 5 100CM DIAGNOSTIC CATHETER, STUCK IN BETWEEN THE CATHETER AND VESSEL AND WAS UNABLE TO RETRIEVE BACK.TOP LEFT IMAGE: IMAGE OF LABEL REVEALING 4F JL5 INFINITI CATHETER WITH CATALOG NUMBER 538-422, LOT NUMBER 17953409 AND USE BY DATE: 2023-05-31,TOP RIGHT IMAGE: MAGNIFICATION OF DAMAGES REVEALS A KINKED BENT CONDITION TO THE BODY OF THE CATHETER. A CRACK IS OBSERVABLE ON ONE CREASE OF THE KINK/BEND. ONE PUNCTURE HOLE IS SEEN BELOW THE KINKED/BENT CONDITION. BOTTOM IMAGE: THE DISTAL TIP OF THE CATHETER IS SEEN AND INDICATES THE DAMAGES TO THE CATHETER OCCURRED ON THE DISTAL PORTION OF THE CATHETER'S BODY. THE PUNCTURE HOLE IS PROXIMAL TO THE KINKED/BENT/CRACKED CONDITION. THERE WAS NO REPORTED PATIENT INJURY AND RECOVERED AFTER THE EVENT. A .035 GUIDEWIRE WAS USED TO GO THROUGH THE CATHETER. THE PUNCTURE/CUT WAS NOT NOTICED BEFORE THE DEVICE WAS USED OR AFTER IT WAS REMOVED FROM THE PATIENT. THERE WERE NO DAMAGES NOTICED TO THE CATHETER BEFORE IT WAS USED.THE INTENDED PROCEDURE WAS A DIAGNOSTIC ANGIOGRAPHY. THE VESSEL / LESION CHARACTERISTICS WAS THE CORONARY ARTERY DISEASE, THERE WAS VESSEL TORTUOSITY. THE LESION WAS CALCIFIED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12953709 ↗
Other CATHETER, INTRAVASCULAR, DIAGNOSTIC devices
- TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator 466P306AUCordis Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC6 deaths186 reports
- Dragonfly™ OPTIS™ C408646Lightlab Imaging, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC4 deaths150 reports
- Dragonfly OpStar™ 1014651Lightlab Imaging, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall87 reports
- LANGSTON IPN913559Teleflex Incorporated · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls14 reports
- Trevo 90238Stryker Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls5 reports
- Expo™ H749085263011Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls3 reports
- Expo™ H74908526501Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls1 report
- Expo™ H74908526031Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls0 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page