ExpanSure Large Access Transseptal Dilator ESD125-35-67-70-NRecalls & reported problems
Baylis Médicale Cie Inc · One transseptal dilator; one J-tip guidewire. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00685447004691), received between Jul 15, 2022 and Jul 15, 2022 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pericardial Effusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE VERSACROSS RF WIRE AND THE VERSACROSS TRANSSEPTAL SHEATH WERE USED FOR TRANSSEPTAL PUNCTURE DURING A CRYO ABLATION PROCEDURE. UPON SUCCESSFUL TRANSSEPTAL PUNCTURE, THE PHYSICIAN EXCHANGED THE VERSACROSS TRANSSEPTAL SHEATH WITH THE CRYO SHEATH AND DILATOR. THE PHYSICIAN ATTEMPTED TO DILATE THE SEPTUM FURTHER USING THE CRYO DILATOR BUT THE CRYO SHEATH WAS UNABLE TO CROSS. THE CRYO SHEATH AND DILATOR WERE REMOVED AND THE EXPANSURE LARGE ACCESS TRANSSEPTAL DILATOR WAS USED IN AN ATTEMPT TO FURTHER DILATE THE SEPTUM. THE CRYO SHEATH AND DILATOR WERE ATTEMPTED AGAIN BUT WAS AGAIN UNSUCCESSFUL. DURING PREPARATION FOR A SECOND TRANSSEPTAL PUNCTURE, THE DEVICES WERE REMOVED FROM THE LEFT ATRIUM AND A DROP OF PRESSURE WAS OBSERVED. A PERICARDIAL EFFUSION WAS OBSERVED ON FLUOROSCOPY AND A PERICARDIAL EFFUSION TAP PROTOCOL WAS INITIATED. AS BAYLIS MEDICAL DEVICES WERE REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. A SEPARATE MDR PROBLEM REPORT HAS BEEN SUBMITTED FOR THE VERSACROSS RF WIRE AND VERSACROSS TRANSSEPTAL SHEATH UNDER MFR REPORT NUMBER: 3019751610-2022-00015 AND 3019751610-2022-00014.
Patient problems: Pericardial Effusion
MAUDE report 15031432 ↗
Other Dilator, Vessel, For Percutaneous Catheterization devices
- VersaCross Connect LAAC Access Solution VXAK0007Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization3 deaths108 reports
- TandemLife 5740-2417Cardiacassist, Inc. · Dilator, Vessel, For Percutaneous Catheterization2 recalls0 reports
- TightRail Rotating Dilator Sheath 545-513Spectranetics Corporation · Dilator, Vessel, For Percutaneous Catheterization20 deaths74 reports
- VersaCross Connect LAAC Access Solution VXAK0003Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization2 deaths70 reports
- VersaCross Connect LAAC Access Solution VXAK0007Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization2 deaths54 reports
- AVANTI 504656XCordis Corporation · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall2 reports
- Mini Stick MAX H965457510Angiodynamics, Inc. · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall1 report
- Abiomed® 00884450732311Merit Medical Systems, Inc. · Dilator, Vessel, For Percutaneous Catheterization1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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