SUPER TORQUE 533620Recalls & reported problems
Cordis Corporation · CATH F6 ST+ JL 4 100CM · Class 2
All models of SUPER TORQUE (11)
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 10705032013031), received between Aug 20, 2025 and Aug 20, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
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.
MalfunctionAug 20, 2025Leak/Splash; Leak/Splash
AS REPORTED, A LEAK WAS OBSERVED AT THE TOP PORTION OF A 6F 100 CM JUDKINS LEFT (JL4) SUPER TORQUE PLUS DIAGNOSTIC CATHETER FOLLOWING INSERTION AND CONTRAST INJECTION. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT DETAILS WERE REQUESTED BUT COULD NOT BE OBTAINED. THE DEVICE WAS NOT RETURNED FOR EVALUATION AS INITIALLY ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22853660 ↗
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- 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.
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