Attain Command™ + SureValve™ 6250VC (UDI 00643169143289)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169143289), received between Oct 10, 2017 and Nov 14, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RADIOPAQUE TIP OF THE DILATOR BROKE OFF THE CATHETER INTO A FEW PIECES INSIDE THE PATIENT DURING LEAD IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8068061 ↗
• InjuryOct 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT PROCEDURE OF THE LEFT VENTRICULAR (LV) LEAD, THE PATIENT EXPERIENCED A PERFORATION. IT WAS NOTED DURING THE PROCEDURE, THE CORONARY SINUS WAS LOCATED AND A SHEATH WAS ADVANCED INTO THE CORONARY SINUS AND A BALLOON VENOGRAPHY LOCATED THE TARGET VESSEL. THE LATERAL TARGET VESSEL WAS CANNULATED WITH A SUBSELECTING CATHETER AND THEN A SECOND SUBSELECTING CATHETER WAS ADVANCED INTO THE TARGET BUT A VENOGRAPHY REVEALED THE DISTAL PERFORATION. ALL THE LEADS AND SHEATHS WERE REMOVED. A PERICARDIAL TAP WAS PERFORMED AND DRAINED. THE POCKET WAS CLOSED AND THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE. A SECOND PERICARDIAL TAP WAS PERFORMED AT A DIFFERENCE ANGULATION. ADDITIONAL DRAINAGE OCCURRED AND ULTIMATELY THE DRAINAGE STOPPED WITH A SMALL RESIDUAL EFFUSION AND THE PATIENT REMAINED STABLE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Perforation of Vessels; Pericardial Effusion

  MAUDE report 6937145 ↗