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SofTIP 60-02Recalls & reported problems

Atricure, Inc. · SofTIP Guide Cannula · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10840143904417), received between Feb 17, 2023 and Feb 17, 2023 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Cardiac Perforation1

Recent adverse event reports

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

  • InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2023 A PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE MANAGEMENT PROCEDURE UTILIZING THE LARIAT SUTURE DEVICE WITH CONCOMITANT CONVERGENT PROCEDURE. THE SOFTIP GUIDE CANNULA WAS PASSED WITHOUT A GUIDEWIRE IN PLACE THROUGH THE PERICARDIAL WINDOW. DURING PLACEMENT, THE RIGHT VENTRICLE WAS PUNCTURED. PROCEDURE WAS CONVERTED TO AN OPEN CHEST PROCEDURE VIA MEDIAN STERNOTOMY AND THE INJURY WAS REPAIRED WITH SUTURES. PATIENT WAS STABLE AND THE CONVERGENT PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

    Patient problems: Cardiac Perforation

    MAUDE report 16400672 ↗

Other Suture, Nonabsorbable, Synthetic, Polyethylene devices

All Suture, Nonabsorbable, Synthetic, Polyethylene devices →

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