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Confida™ CES122230Recalls & reported problems

Medtronic, Inc. · SHEATH CES122230 CONFIDA US 1YSL · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000233815), received between Mar 20, 2020 and Mar 20, 2020 — classified as 1 injury.

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

  1. May 12, 2020Terminated

    Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)

    Z-2039-2020 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Vascular Dissection1

Recent adverse event reports

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

  • InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, VIA RIGHT FEMORAL ARTERY (RFA) ACC ESS, IT WAS VERY DIFFICULT TO INSERT THE 34MM DELIVERY CATHETER SYSTEM (DCS) THROUGH THE MEDTRONIC SHEATH, BUT IT WAS INSERTED WITH SIGNIFICANT PUSHING. AFTER VALVE IMPLANT, WHEN THE DCS WAS WITHDRAWN THROUGH THE SHEATH, THE MARKER BAND ON THE SHEATH RETRACTED OR "ACCORDIONED" BACK TO THE RFA. THE RIGHT EXTERNAL ILIAC ARTERY AND RIGHT COMMON ILIAC ARTERY VESSELS APPEARED TO BE DISSECTED AFTER REMOVAL OF THE SHEATH AND DCS. THERE WAS LIMITED BLOOD FLOW GOING TO THE RIGHT LEG. A RFA CUTDOWN PROCEDURE WAS PERFORMED. MULTIPLE STENTS WERE IMPLANTED IN THE ILIACS AND A SURGICAL PATCH WAS PLACED IN THE RFA. THE SURGEON STATED THAT THE VESSEL SHOULD NOT HAVE DISSECTED AS IT WAS BIG ENOUGH TO ACCOMMODATE THE DEVICE AND THE SHEATH. THE PHYSICIAN THOUGHT THE SHEATH TORE THE INTIMA OF THE VESSEL FROM THE ILIAC BIFURCATION TO THE START OF THE RFA AND DISSECTED THE ENTIRE VESSEL. THE PATIENT WAS REPORTED TO BE DOING OKAY FOLLOWING VESSEL REPAIR. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: Vascular Dissection

    MAUDE report 9860400 ↗

Other INTRODUCER, CATHETER devices

All INTRODUCER, CATHETER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.