Attain Command™ + SureValve™ 6250VSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000160364), received between Aug 11, 2022 and Aug 11, 2022 — classified as 1 death.

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.

• DeathAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THE LEFT VENTRICULAR (LV) LEAD AND USE OF THE CATHETER, IT WAS OBSERVED THAT THE GUIDEWIRE AND THE LEAD WERE ADVANCING DOWN A NON-VISUALIZED PATH ON THE VENOGRAM. A CORONARY SINUS DISSECTION HAD OCCURRED, THE PATIENT'S BLOOD PRESSURE WAS LOW, AND A CODE WAS CALLED. THE LEAD, THE CATHETER, THE SHEATH AND THE GUIDEWIRE WERE REMOVED IMMEDIATELY. PERICARDIAL EFFUSION AND TAMPONADE FROM THE PERFORATION WERE OBSERVED. PULSELESS ELECTRICAL ACTIVITY (PEA) WAS DIAGNOSED AND RESCUE ATTEMPTS WERE PERFORMED. THE PHYSICIAN PERFORMED A STERNOTOMY TO EVACUATE THE CAVITY AND REPAIR HEART. BLOOD AND FLUID WAS SUCCESSFULLY REMOVED TO RELIEVE TAMPONADE AND THE TEAR WAS SURGICALLY REPAIRED. THE PATIENT WAS GIVEN FOUR UNITS OF BLOOD. THE PATIENT WAS UNABLE TO BE RESUSCITATED AND PASSED AWAY.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Perforation; Pericardial Effusion; Vascular Dissection

  MAUDE report 15212274 ↗