ASSURANT® COBALT ASC860SVRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994931115), received between Mar 21, 2017 and Mar 21, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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.

• InjuryMar 21, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE PHYSICIAN INTENDED TO USE AN ASSURANT COBALT BARE METAL STENT TO TREAT A LESION LOCATED IN THE RT COMMON/EXTERNAL ILIAC. THE LESION REPORTED TO BE SEVERELY CALCIFIED, MODERATELY TORTUOUS WITH 75% STENOSIS. CALCIFIED STENOSIS OF RT EXTERNAL ARTERY WAS ALSO NOTED. PRIOR TO THE PROCEDURE, THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER THE IFU AND NO ISSUES WERE IDENTIFIED. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE ASSURANT COBALT (8X30MM ) IN THE RT OSTIAL ILIAC, AND THEN WHEN ATTEMPTING TO IMPLANT A SECOND ASSURANT COBALT (8X60MM), THE PHYSICIAN FOUND A FOREIGN BODY DISTAL TO THE STENT IN THE VESSEL. THE PHYSICIAN DEPLOYED THE SECOND STENT, ASKED FOR A SNARE BUT WAS NEVER USED AND THEN USED A THIRD ASSURANCE COBALT (8X30MM) STENT TO JAIL THE FOREIGN BODY AGAINST THE ARTERIAL WALL AND ENDED THE CASE. THE PHYSICIAN THEN REQUESTED A MYNX CLOSURE TO CLOSE THE PUNCTURE SITE. NO FURTHER CLINICAL SEQUELAE WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6420128 ↗