Attain Command™ + SureValve™ 6250V-MP (UDI 00763000160326)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000160326), received between May 5, 2021 and Mar 23, 2026 — classified as 1 death, 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE HUB OF THE CATHETER PARTIALLY DETACHED FROM THE CATHETER WHILE SLITTING. THE PHYSICIAN EXPRESSED CONCERN THAT THE HUB WOULD COMPLETELY DETACH, MAKING SLITTING VIRTUALLY IMPOSSIBLE. THE PHYSICIAN NOTED THAT THIS HAS BEEN AN ISSUE MORE RECENTLY. THE CATHETER WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664132 ↗
• MalfunctionNov 6, 2024Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT DURING USE OF THE DELIVERY, THE PRODUCT WAS NOTED TO BE EXPIRED.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20623250 ↗
• MalfunctionJul 22, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED BY THE PHYSICIAN THAT DURING THE IMPLANT PROCEDURE, THE SLITTER WOULD NOT PROPERLY SLIT. IT WAS ¿JUST SHAVING THE SHEATH¿ AND NOT CUTTING/SLITTING THE DELIVERY CATHETER SHEATHS. THE PHYSICIAN REPLACED THE SLITTER AND WAS ABLE TO SLIT THE DELIVERY CATHETER SHEATHS WITHOUT ISSUE. THE DELIVERY CATHETERS WERE REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19801834 ↗
• DeathJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION OCCURRED DURING THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM IMPLANT. A SMALL EFFUSION HAD BEEN NOTED VIA ECHOCARDIOGRAM PRIOR TO THE PROCEDURE. THE EFFUSION WAS NOTED TO BE LARGER, THOUGH STILL INSIGNIFICANT, DURING THE IMPLANT. THE PATIENT EXPIRED DUE TO HYPOXIC RESPIRATORY FAILURE NINE DAYS LATER, THOUGH THE DEATH WAS REPORTEDLY UNRELATED TO THE SYSTEM.

  Patient problems: Hypoxia; Pericardial Effusion; Respiratory Failure

  MAUDE report 16218371 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DELIVERY CATHETER DISSECTED THE CORONARY SINUS DURING CANNULATION. NO LEAD WAS IMPLANTED VIA THE CORONARY SINUS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Perforation of Vessels

  MAUDE report 15075950 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, A DISSECTION OCCURRED WHILE THE PHYSICIAN WAS USING A STEERABLE QUADRIPOLAR CATHETER DURING CORONARY SINUS CANNULATION. IT WAS NOTED THAT THE VENOUS DISSECTION WAS MILD. THE PHYSICIAN MONITORED THE PATIENT BLOOD PRESSURE, AND THE PROCEDURE WAS CONTINUED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 12832391 ↗
• InjuryOct 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, A CORONARY SINUS DISSECTION OCCURRED DURING THE USE OF THE CATHETER. IT WAS NOTED THAT THE PATIENT HAD A STENOSED CORONARY SINUS. THE CATHETER WAS REMOVED AND THE IMPLANT PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 12623601 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE OF UPGRADING PACEMAKER TO CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), WHEN ACCESSING THE CORONARY SINUS WITH THE GUIDE CATHETER AT SOME POINT THE CATHETER MOST LIKELY CAUSED A PERFORATION AND PERICARDIAL EFFUSION THAT WAS TREATED WITH A PERICARDIOCENTESIS. THE GUIDE CATHETER WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 11797966 ↗
• MalfunctionMay 5, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, AFTER THE PHYSICIAN SEATED THE UNIVERSAL SLITTER AND APPLIED FORCE TO SLICE THE CATHETER, THE SHEATH BROKE, AND A PIECE FELL OFF. IT WAS NOTED THAT ONCE A PIECE OF THE SHEATH BROKE OFF IT WAS HARDER TO SPLIT THE CATHETER FROM THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11777388 ↗