ExpanSure Transseptal Dilation System ESD125-35-67-70-NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00685447003021), received between May 15, 2019 and May 15, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THROUGH INTERNAL INVESTIGATIONS, BAYLIS MEDICAL COMPANY INC. HAS BECOME AWARE OF A POTENTIAL FOR THE PRESENCE OF PARTICLES IN THE LUMEN OF THE EXPANSURE TRANSSEPTAL DILATOR (CONTAINED IN THE EXPANSURE TRANSSEPTAL DILATION SYSTEM). THERE HAVE BEEN NO REPORTS OF ADVERSE EVENTS ASSOCIATED WITH THIS ISSUE. BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT DUE TO THE REMOTE POSSIBILITY OF PARTICLES BEING RELEASED INTO THE PATIENT DURING USE OF THE DEVICE. THIS REPORT PERTAINS TO THE SECOND OF THREE DEVICES (LOT NUMBER ESFA140319) THAT HAVE BEEN USED IN CASES IN THE USA TO DATE. THERE ARE NO OTHER AFFECTED DEVICES REMAINING IN THE FIELD IN THE USA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8612273 ↗
• MalfunctionMay 15, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THROUGH INTERNAL INVESTIGATIONS, BAYLIS MEDICAL COMPANY INC. HAS BECOME AWARE OF A POTENTIAL FOR THE PRESENCE OF PARTICLES IN THE LUMEN OF THE EXPANSURE TRANSSEPTAL DILATOR (CONTAINED IN THE EXPANSURE TRANSSEPTAL DILATION SYSTEM). THERE HAVE BEEN NO REPORTS OF ADVERSE EVENTS ASSOCIATED WITH THIS ISSUE. BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT DUE TO THE REMOTE POSSIBILITY OF PARTICLES BEING RELEASED INTO THE PATIENT DURING USE OF THE DEVICE. THIS REPORT PERTAINS TO THE FIRST OF THREE DEVICES (LOT NUMBER ESFA140319) THAT HAVE BEEN USED IN CASES IN THE USA TO DATE. THERE ARE NO OTHER AFFECTED DEVICES REMAINING IN THE FIELD IN THE USA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8612268 ↗
• MalfunctionMay 15, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THROUGH INTERNAL INVESTIGATIONS, BAYLIS MEDICAL COMPANY INC. HAS BECOME AWARE OF A POTENTIAL FOR THE PRESENCE OF PARTICLES IN THE LUMEN OF THE EXPANSURE TRANSSEPTAL DILATOR (CONTAINED IN THE EXPANSURE TRANSSEPTAL DILATION SYSTEM). THERE HAVE BEEN NO REPORTS OF ADVERSE EVENTS ASSOCIATED WITH THIS ISSUE. BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT DUE TO THE REMOTE POSSIBILITY OF PARTICLES BEING RELEASED INTO THE PATIENT DURING USE OF THE DEVICE. THIS REPORT PERTAINS TO THE THIRD OF THREE DEVICES (LOT NUMBER ESFA140319) THAT HAVE BEEN USED IN CASES IN THE USA TO DATE. THERE ARE NO OTHER AFFECTED DEVICES REMAINING IN THE FIELD IN THE USA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8612262 ↗