Dissector GPD1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10840143902130), received between Jan 2, 2025 and Jan 2, 2025 — 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

Recent adverse event reports

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

• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A MITRAL VALVE REPAIR/REPLACEMENT VIA MEDIAN STERNOTOMY WITH CONCOMITANT PULMONARY VEIN ISOLATION USING A GPD1. THE GPD1 WAS USED TO DISSECT AROUND THE LEFT PULMONARY VEINS. SHORTLY AFTER USING THE EMT1 TO ABLATE THE LEFT PULMONARY VEINS, A SMALL TEAR WAS IDENTIFIED AT THE JUNCTION OF THE LEFT SUPERIOR PULMONARY VEIN AND THE POSTERIOR WALL OF THE LEFT ATRIUM. THE TEAR WAS REPAIRED WITH PROLENE SUTURES. THE LEFT ATRIAL APPENDAGE WAS EXCISED, AND THE OPENING WAS USED TO CLOSE THE TEAR. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Cardiac Perforation

  MAUDE report 21061527 ↗