SuperCable® ISO-Elastic™ Cerclage System 35-800-2020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818720011363), received between Jun 25, 2025 and Jun 25, 2025 — classified as 1 death.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathJun 25, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  REPORTER'S OWN WORDS: STRAIGHT TENSIONER [35-800-2020] WAS BROKEN BEFORE THE START OF THE CASE. THE DEPLOYMENT POST WAS BENT SO UNUSABLE. WE THEN HAD TO USE THE ANGLED TENSIONER WHICH IS DIFFICULT TO USE AND NOT IDEAL. IN THE MIDDLE OF THE CASE IT [ASSUMED TO REFER TO 35-800-7000] FELL APART. WE THEN HAD TO PUT IT BACK TOGETHER ENOUGH SO WE COULD USE IT TO COMPLETE THE CASE. IN TOTAL I [REPORTER] FEEL IT ADDED AN HOUR AT LEAST TO A VERY DIFFICULT PROCEDURE. PATIENT WAS ELDERLY AND UNWELL SO TIME IS IMPORTANT TO GET HIM OUT OF THEATRE AS QUICKLY AS POSSIBLE. PATIENT HAS A PERI PROSTHETIC FRACTURE THAT NEEDED TO BE REPAIRED. AS THE SURGEON WAS APPLYING STAPLES TO CLOSE THE WOUND AT THE END OF THE CASE, THE PATIENT'S CARDIAC STATUS BECAME UNSTABLE. THE TOTAL OPERATION WAS LONG AND COMPLEX, TOOK ABOUT 5 HOURS AND INVOLVED REMOVAL OF A CEMENTED STEM AND IMPLANTATION OF A REVISION STEM. SUBSEQUENT REPORT FROM DISTRIBUTOR: ELDERLY PATIENT UNDERWENT FEMORAL PERI-PROSTHETIC FRACTURE REPAIR PROCEDURE USING CABLE FIXATION, PLATE, AND HIP STEM. DURING THE PROCEDURE THERE WAS A DELAY OF APPROXIMATELY 60 MINUTES DUE TO INSTRUMENT MALFUNCTION. THE REPAIR WAS COMPLETED AND DURING CLOSURE, THE PATI

  Patient problems: Cardiac Arrest

  MAUDE report 22329669 ↗