SUPER TORQUE 533593Recalls & reported problems
Cordis Corporation · CATH MULTIPAC 5.2F STP · Class 2
Data updated Oct 13, 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 10705032012966), received between Aug 6, 2019 and Aug 6, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Puncture/Hole1
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.
MalfunctionAug 6, 2019Material Puncture/Hole; Material Puncture/Hole
AS REPORTED, THE SUPER TORQUE CATHETER CATH F5.2+ PIG 145 DEGREE 110CM 6SH WAS USED AND BLOOD WAS OOZING FROM WHAT APPEARS TO BE A SMALL HOLE AT THE PROXIMAL END BY THE HUB OF THE CATHETER SHAFT WAS OBSERVED. THERE WERE NO REPORTED PATIENT INJURIES. THE CATHETER WAS REMOVED FROM THE PACKAGING AND FLUSHED PER USUAL PRACTICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ADVERSE EVENT. THE DEVICE WAS STORED IN THE CATH LAB HANGING IN THE STERILE POUCH. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THERE WERE NO ANOMALIES NOTED TO THE DEVICE WHEN IT WAS TAKEN OUT OF THE PACKAGING. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE PACKAGING. THE PATIENT IS CURRENTLY DOING WELL AND WAS UNAFFECTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8865897 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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