CP Stent™ 614509Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046955091829), received between Dec 3, 2019 and Dec 3, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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

Recent adverse event reports

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

• MalfunctionDec 3, 2019Material Fragmentation

  AS PER THE REPORT FROM THE DISTRIBUTOR / USER FACILITY - "WHEN TRYING TO DEPLOY, SOME OF THE OUTER COATING STARTED TO COME OFF. PHYSICIAN MANAGED TO REMOVE THE REST OF IT, AND KEEP THE STENT IN PLACE. IMPLANT WAS USED FOR PLACING, TO MAKE A STABLE LANDING ZONE FOR POSSIBLE TRANSCATHETER VALVE PLACEMENT. THE STENT DID NOT SLIP. THERE WAS NO DIFFICULTY WHILE INSERTING THE BIB/STENT INTO THE INTRODUCER. THE BLUE INTRODUCER TOOL PROVIDED BY NUMED WAS NOT USED. THEY DID NOT ATTEMPT TO PULL THE STENT BACK THROUGH THE HEMOSTASIS VALVE AT ANY TIME. CONTRAST WAS USED IN THE BALLOON TO VISUALIZE AND SALINE WAS USED TO WIPE THE EXCHANGE WIRE. AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED. THE INTRODUCER SHEATH USED WAS 18FR 85CM LENGTH. THE CATHETER SHAFT WAS NOT KINKED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT ANATOMY. THE PATIENT'S CONDITION POST PROCEDURE WAS GOOD." THE STENT WAS PLACED WITHOUT THE COVERING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9402043 ↗