Attain Command™ + SureValve™ 6250V-EHXL (UDI 00643169142862)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169142862), received between Jun 15, 2018 and Jan 8, 2021 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THERE WAS DIFFICULTY PLACING THE LEFT VENTRICULAR (LV) LEAD. ADDITIONAL INFORMATION REPORTED THE LEAD WAS UNABLE TO BE PLACED DUE TO A PERFORATION FROM THE GUIDE CATHETER. THE LV LEAD AND CATHETER WERE REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Perforation

  MAUDE report 11139673 ↗
• InjuryJun 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AS THE PHYSICIAN WAS ATTEMPTING TO PLACE THE GUIDE CATHETER AND BALLOON CATHETER INTO THE CORONARY SINUS, A DISSECTION OCCURRED. A LEFT VENTRICULAR (LV) LEAD WAS NOT PLACED AND THE PATIENT WILL BE EVALUATED AT A LATER DATE FOR A POSSIBLE EPICARDIAL LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 7606587 ↗