SITESEER™ 06SR050Recalls & reported problems
Medtronic, Inc. · CATH 06SR050 SS 5PK6F EBU 3.5 100CM SPL. · 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 00613994943484), received between May 6, 2022 and May 6, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (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 Twisted/Bent1
- Physical Resistance/Sticking1
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.
MalfunctionMay 6, 2022Material Twisted/Bent; Physical Resistance/Sticking
GUIDED CATH BECAME KINKED DURING CASE: PATIENT WAS HAVING A CARDIAC CATHETERIZATION. WHEN THE PHYSICIAN WAS USING A PRESSURE WIRE, THE WIRE BECAME STUCK IN THE GUIDE CATHETER. THE ENTIRE SYSTEM WAS REMOVED. THE CATHETER WAS FOUND TO HAVE A KINK APPROX 30CM FROM THE DISTAL END. A NEW GUIDE CATHETER AND PRESSURE WIRE WAS INSERTED. THE CASE WAS COMPLETED. THERE WAS NO HARM TO THE PATIENT. THERE WAS ANOTHER CATH THAT HAD THE SAME ISSUE BUT WAS NOT USED IN PATIENT. THE ISSUE WAS FELT BY THE PROVIDER PRIOR TO PROCEDURE. NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14309686 ↗
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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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