VersaCross Steerable Sheath VST85-35-BD-71M-D0Recalls & reported problems
Baylis Médicale Cie Inc · 1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire; 1 x VersaCross Transseptal Dilator · 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 00685447005759), received between Jun 3, 2022 and Jun 3, 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.
InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CASE OF PERICARDIAL EFFUSION REQUIRING INTERVENTION WAS REPORTED DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, WHERE THE BAYLIS MEDICAL, VERSACROSS STEERABLE SHEATH (VST), VERSACROSS TRANSSEPTAL SHEATH (VXS) AND VERSACROSS RF WIRE (VXW) WERE USED FOR THE INITIAL TRANSSEPTAL PUNCTURE. THE VST WAS WIRED WITH THE VXW AND INSERTED IN THE PATIENT. DUE TO COMPLEX PATIENT ANATOMY, THE PHYSICIAN EXPERIENCED DIFFICULTY MANEUVERING THE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) PROBE TO VISUALIZE TENTING OF THE SEPTUM. THE PHYSICIAN ATTEMPTED TO REWIRE AND RE-POSITION THE VST ON THE SEPTUM SIX MORE TIMES. TENTING OF THE SEPTUM COULD NOT BE CONFIRMED DUE TO POOR IMAGING AND THE VST WAS EXCHANGED WITH THE VXS. THE VXS WAS SHAPED, WIRED AND INSERTED FOR POSITIONING. WITH NO CLEAR IMAGING OF THE SEPTUM OR THE VXS, THE PHYSICIAN REQUESTED ANOTHER SIZED SHEATH. BEFORE THE SHEATH COULD BE EXCHANGED, THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP. A PERFORATION LEADING TO PERICARDIAL EFFUSION WAS NOTED IN THE RIGHT ATRIAL APPENDAGE. THE LAAC PROCEDURE WAS ABORTED. PERICARDIOCENTESIS WAS PERFORMED. CARDIOTHORACIC SURGERY WAS CONSULTED. MORE FLUID WAS REMOVED AND THE PATIENT WAS STABILIZED. THERE
Patient problems: Pericardial Effusion
MAUDE report 14597527 ↗
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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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