STABILIZER 527180ERecalls & reported problems
Cordis Corporation · SGW .014 STABILIZER 180CM · Class 2
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 10705032056403), received between Sep 13, 2021 and Sep 13, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Separation Failure” (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
- Separation Failure1
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.
MalfunctionSep 13, 2021Separation Failure; Separation Failure
DURING A SUBINTIMAL RECANALIZATION, A .014¿ 180CM STABILIZER STEERABLE GUIDEWIRE (SGW) WAS EXCHANGED FROM ANOTHER WIRE TO FACILITATE THE USE OF AN 80CM OUTBACK ELITE RE-ENTRY CATHETER. THE OUTBACK CATHETER WAS INSERTED OVER THE STABILIZER GUIDEWIRE UNTIL IT REACHED THE DESIRED POSITION FOR RE-ENTRY. AFTER THAT, AN ATTEMPT TO RETRACT THE STABILIZER GUIDEWIRE FROM THE OUTBACK GUIDEWIRE LUMEN TO EXIT THE NEEDLE FOR THE RE-ENTRY IN THE TRUE LUMEN FAILED. THE TIP OF THE STABILIZER GUIDEWIRE WAS APPROXIMATELY 9MM OUTSIDE THE DISTAL TIP OF THE OUTBACK CATHETER AND DID NOT MOVE FURTHER INSIDE. HENCE, THE STABILIZER GUIDEWIRE AND THE OUTBACK WERE PULLED OUTSIDE THE VESSEL ALTOGETHER. OUTSIDE THE PATIENT AND DURING AN INSPECTION OF THE DEVICE, ANOTHER ATTEMPT WAS MADE TO RETRACT THE DISTAL TIP OF THE STABILIZER GUIDEWIRE AND IT SEPARATED. A NEW .014 STABILIZER GUIDEWIRE AND OUTBACK RE-ENTRY CATHETER WERE USED TO FINISH THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. INITIALLY, AFTER SUBINTIMAL CROSSING OF A LONG OCCLUSION USING A GUIDEWIRE AND CATHETER, A PTA BALLOON WAS USED TO PREDILATE THE SUBINTIMAL SPACE AS PREPARATION FOR SUBINTIMAL RECANALIZATION. THERE WAS NO DAMAGE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12459950 ↗
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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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