SUPER TORQUE 532549H0Recalls & reported problems
Cordis Corporation · CATH ST 5F VER 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 10705032011938), received between Nov 9, 2020 and Nov 9, 2020 — 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.
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 9, 2020Leak/Splash; Leak/Splash
AS REPORTED, A 5F 100CM VERTEBRAL (VER) SUPER TORQUE CATHETER WAS LEAKING FROM THE HUB ON FLUSH AND ASPIRATION. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED AS PER LABELING. THE DEVICE WAS OPENED IN A STERILE FIELD. THE PROCEDURE WAS A STANDARD CEREBRAL ANGIOGRAM. THE VESSEL LEVEL OF ANGULATION, CALCIFICATION AND TORTUOSITY IS NONE. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTION FOR USE (IFU). THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE DURING WITHDRAWAL FROM PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO INSERTION INTO THE PATIENT. THE CATHETER WAS NOT TORQUED AGAINST RESISTANCE. DURING PROCEDURE THERE WAS AIR LEAKAGE NOTED INTO SYRINGE ON FIRST ASPIRATION OF CATHETER AFTER IT HAD BEEN NAVIGATED UNEVENTFULLY INTO THE COMMON CAROTID ARTERY. THIS CATHETER WAS REMOVED AND A SECOND CATHETER WAS INSERTED IN A SIMILAR MANNER. SAME PROBLEM OCCURRED. ON REMOVAL OF THIS CATHETER FROM THE PATIENT, A LEAK OF SALINE WAS OBSERVED
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10813335 ↗
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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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