Attain Command™ + SureValve™ 6250V-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169142831), received between Dec 2, 2020 and Dec 2, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (1 report).

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.

• MalfunctionDec 2, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD DISLODGED MULTIPLE TIMES DURING AN ATTEMPTED IMPLANT PROCEDURE. IT WAS DIFFICULT TO DETERMINE IF THIS WAS DUE TO PATIENT ANATOMY, DEEP SNORING BY THE PATIENT DURING THE PROCEDURE OR THE CATHETER. IT WAS ADDITIONALLY REPORTED THAT WHEN THE CATHETER WAS SPLIT THE CURVE PUT SUSPECTED STRESS ON THE IMPLANTED LEAD, WHICH COULD HAVE CONTRIBUTED TO THE REPEATED DISLODGEMENT. THE PHYSICIAN NOTED THEY WOULD LIKE BETTER TRACKING AND STABILITY DURING SLITTING WITH THIS TYPE OF CATHETER. THE LEAD WAS NOT USED, AND A NEW LEAD WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10935037 ↗