SUPERTORQUE 533565Recalls & reported problems
Cordis Corporation · CATH F5.2ST+ JR 4 125CM · Class 2
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 10705032012782), received between Jul 7, 2024 and Jul 7, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED, THE PATIENT FELL INTO ANAPHYLACTIC SHOCK DURING A CARDIAC PROCEDURE WITH THE USE OF A 0.035IN FIXED-CORE J- CURVE 3MM X 175CM EMERALD DIAGNOSTIC GUIDEWIRE, THREE 5F JUDKIN'S LEFT (JL) 4 100CM INFINITI DIAGNOSTIC CATHETER, AND A 5.2F JUDKIN'S RIGHT (JR) 4 125CM SUPER TORQUE PLUS DIAGNOSTIC CATHETER. THERE WERE NO REPORTS OF PATIENT INJURY. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE. THE PRODUCT WAS INSPECTED BEFORE USE AND APPEARED TO BE NORMAL. NO INFORMATION WAS PROVIDED REGARDING THE ACTIONS PERFORMED ON THE GUIDEWIRE TO PREPARE IT FOR USE, BUT NO SPECIAL PROBLEMS WERE DETECTED DURING THE PREPARATION. THE GUIDEWIRE WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS REMOVED EASILY AND INTACT FROM THE PATIENT. THE CARDIAC PROCEDURE WAS COMPLETED SUCCESSFULLY AT (B)(6) IN GENEVA. THE PATIENT'S CONDITION IS COMPLETELY STABLE, AND THEY HAVE BEEN AT HOME FOR SEVERAL MONTHS. HOWEVER, THEY WILL NEED TO UNDERGO A NEW PROCEDURE IN THE COMING WEEKS. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE USED MONTHS AGO, AND THE DEVICES ARE NO LONGER AVAILABLE.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 19686027 ↗
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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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