Edwards 23F Guide Sheath 9880GSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103219784), received between Apr 22, 2026 and Apr 22, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Air/Gas in Device” (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 16, 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.

• MalfunctionApr 22, 2026Air/Gas in Device

  EDWARDS RECEIVED A REPORT OF A SAPIEN M3 PROCEDURE IN THE MITRAL POSITION IN WHICH AN ANEURYSMAL SEPTUM REQUIRED LATERAL ADVANCEMENT OF THE GUIDE SHEATH (GS) TO GAIN LEFT ATRIAL (LA) ACCESS. THE GS APPEARED CLEAR OF TISSUE ON 3D TEE; HOWEVER, EMBOLIZATION OF AIR WAS OBSERVED DUE TO THE GS PULLING AGAINST THE LATERAL WALL DURING GS ASPIRATION AND FLUSHING. THE AIR WAS NOTED AFTER INTRODUCTION OF THE GS INTO THE LEFT ATRIUM AND DURING SUBSEQUENT GUIDE SHEATH AND DOCK STEERABLE CATHETER (DSC) MANIPULATION, APPROXIMATELY MID-PROCEDURE. ADDITIONAL INFORMATION WAS SUBSEQUENTLY RECEIVED FROM THE FIELD, DURING INITIAL GS INSERTION, ASPIRATION RESULTED IN AIR AND SOME BLOOD WHILE THE WIRE AND INTRODUCER WERE POSITIONED ACROSS THE GS SEALS. THE FIRST GS WAS REMOVED AND RE-PREPPED. THE INTERATRIAL SEPTUM WAS BALLOONED, AND THE GS WAS REINSERTED ACROSS THE SEPTUM. WHEN THE REINSERTED GS WAS FLUSHED AND ASPIRATED DURING WIRE AND INTRODUCER REMOVAL, ONLY AIR WAS OBTAINED. THE GS WAS THEN REMOVED AND EXCHANGED FOR A SECOND GS THAT WAS POSITIONED LATERALLY. DURING ASPIRATION OF THE SECOND GS ASSOCIATED WITH WIRE AND INTRODUCER REMOVAL, BLOOD WAS OBTAINED; HOWEVER, SOME AIR INGRESS WAS OBSERVED, AN

  Patient problems: Air Embolism

  MAUDE report 24955105 ↗