Attain Command™ + SureValve™ 6250V-MPX (UDI 00643169142848)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169142848), received between Feb 8, 2018 and Feb 19, 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.

• InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHILE ATTEMPTING TO DELIVER THE LEFT VENTRICULAR (LV) LEAD INTO THE DISTAL BRANCH OF THE CORONARY SINUS, THE CATHETER CAUSED A PERFORATION. A SMALL PERICARDIAL EFFUSION WAS NOTED UNDER ULTRASOUND. NO PERICARDIOCENTESIS WAS REQUIRED. THE LV LEAD IMPLANT WAS ABANDONED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 11348622 ↗
• InjuryFeb 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DELIVERY CATHETER CAUSED A CORONARY SINUS DISSECTION AS WELL AS INFILTRATION OF THE EPICARDIAL FAT WITH SUBSEQUENT PERICARDIAL EFFUSION. THE PATIENT WAS MONITORED WITH NO CHANGE IN HEMODYNAMICS. A CHEST X-RAY THE FOLLOWING DAY APPEARED NORMAL AND THE PATIENT WAS DISCHARGED. THE PATIENT IS A PARTICIPANT IN THE ATTAIN STABILITY QUAD CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion; Vascular Dissection

  MAUDE report 7257947 ↗