Attain Command™ + SureValve™ 6250V-MP (UDI 00643169142893)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169142893), received between Apr 10, 2018 and Oct 30, 2020 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathOct 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN WAS ATTEMPTING TO GAIN ACCESS TO THE CORONARY SINUS FOR THE LEFT VENTRICULAR (LV) LEAD IMPLANT WHEN THE PATIENT WENT INTO FLASH PULMONARY EDEMA. THE PATIENT'S BLOOD PRESSURE DROPPED ALONG WITH THE OXYGEN SATURATION. THE PATIENT CODED AND CARDIOPULMONARY RESUSCITATION WAS ADMINISTERED FOR ABOUT ONE HOUR, HOWEVER, THE PATIENT DIED.

  Patient problems: Cardiac Arrest; Death; Low Blood Pressure/ Hypotension; Low Oxygen Saturation; Pulmonary Edema

  MAUDE report 10766583 ↗
• MalfunctionDec 4, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT WHEN THE PHYSICIAN WENT TO SLIT THE CATHETER, IT COULD NOT BE SLIT ALL THE WAY THROUGH THE VALVE AND IT HAD TO BE CUT WITH A SCISSORS. THE PHYSICIAN NOTED THAT THIS HAS HAPPENED TO ANOTHER MODEL OF CATHETER ALSO. NO PATIENT COMPLICATIONS HAVEBEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9412519 ↗
• MalfunctionApr 10, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE OF THE LEFT VENTRICULAR LEAD, THE HUB OF THE CATHETER COULD NOT BE SLIT. TWO SLITTERS WERE ATTEMPTED AND THEN SCISSORS WERE USED. IT WAS NOTED THE LEAD DID NOT DISLODGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7415749 ↗