Attain Command™ + SureValve™ 6250V-EH (UDI 00763000160289)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000160289), received between May 10, 2021 and May 9, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Accessory Incompatible” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE CORONARY SINUS WAS ACCESSED WITH TWO DELIVERY CATHETERS AND THERE WAS AN ATTEMPT TO PLACE A LEFT VENTRICULAR (LV) LEAD IN SEVERAL DIFFERENT BRANCHES WITH NO SUCCESS. IT WAS NOTED THAT THERE WAS INTERMITTENT CAPTURE AT HIGH OUTPUTS. IT WAS DECIDED TO DO AN OCCLUDED VENOGRAM FLUOROSCOPY SAVE. THE LV LEAD WAS PLACED IN TWO OTHER BRANCHES AS WELL AND THERE WAS NO CAPTURE. THE DECISION WAS MADE TO ABORT THE CASE AS THE PATIENT¿S BLOOD PRESSURE WAS GETTING LOW AND THERE WERE NO BRANCHES THAT WERE USABLE. THE TWO DELIVERY CATHETERS AND LV LEAD WERE REMOVED FROM THE PATIENT. THE PATIENT THEN COMPLAINED OF DIFFICULTY BREATHING. THE PHYSICIAN CALLED FOR AN ULTRASOUND MACHINE AND THEN A CODE. THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION AND A PERICARDIOCENTESIS PROCEDURE WAS PERFORMED WITH NO COMPLICATIONS. IT WAS NOTED THAT THE EXISTING LEADS WERE NEVER DISCONNECTED, AND THE EXISTING IMPLANTABLE PULSE GENERATOR (IPG) PACING MODE WAS CHANGED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Pericardial Effusion

  MAUDE report 19282809 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, GUIDEWIRE WIRES BECAME UNRAVELED. IT WAS ALSO REPORTED THAT DURING USE OF THE DELIVERY CATHETER VEIN DISSECTION OBSERVED WITH CONTRAST INJECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 18974127 ↗
• MalfunctionJan 12, 2023Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SIGNIFICANT FALL EVENT AND THE LEFT VENTRICULAR (LV) LEAD WAS SUSPECTED TO HAVE LEAD PARTIALLY DISLODGED AS A RESULT OF THE FALL. EVALUATION REVEALED THE LV LEAD WAS FOUND TO BE IN THE TARGET VESSEL BUT HAD RETRACTEDFROM THE INITIAL POSITION DISTAL IN THE VESSEL. AS A RESULT OF THE LEAD RETRACTION, THE THRESHOLD INCREASED TO HIGH OUTPUTS AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) LONGEVITY DROPPED TO LESS THAN TWO YEARS. A LV LEAD REVISION WAS SCHEDULED. DURING THE LV LEAD REVISION AN UNSUCCESSFUL ATTEMPT WAS MADE TO ADVANCE THE LV LEAD OVER A STYLET. A GUIDE CATHETER WAS PLACED AND THE LV LEAD WAS PLACED DISTAL, SECURED IN THE TARGET VESSEL AND LEAD SECURITY WAS TESTED. THE LV LEAD THRESHOLD TESTING WAS PERFORMED AND FOUND TO BE ACCEPTABLE. DURING THE GUIDE CATHETER REMOVAL AND SLITTING THE LV LEAD DISLODGED. THE LV LEAD WAS EXPLANTED AND THE CRT-D REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16147659 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERFORATION OF THE CORONARY SINUS OCCURRED DURING ATTEMPTED LEFT VENTRICULAR (LV) LEAD IMPLANT. THE LEAD HAD BEEN PLACED AND THE DELIVERY CATHETER SLIT WITHOUT DIFFICULTY. IT WAS NOTED UNDER FLUOROSCOPY THAT THE LEAD HAD PULLED BACK SLIGHTLY. THE PHYSICIAN WAS PREPARING TO REPOSITION THE LEAD WHEN A DROP IN THE PATIENT'S BLOOD PRESSURE AND DETERIORATING VITALS WERE NOTED. THE LEAD AND CATHETER WERE REMOVED. THE PATIENT BECAME UNSTABLE AND CODED AND AN ECHOCARDIOGRAM CONFIRMED CARDIAC TAMPONADE. CARDIOPULMONARY RESUSCITATION WAS STARTED AND A PERICARDIAL THORACENTESIS WAS PERFORMED. THE PERFORATION REQUIRED OPENING OF THE CHEST, A BLOOD TRANSFUSION, AND SURGICAL REPAIR OF THE MID-CORONARY SINUS. THE PATIENT WAS ADMITTED TO INTENSIVE CARE UNIT (ICU) IN AN INTUBATED BUT STABLE STATE. IT IS UNKNOWN IF THE LEAD OR THE CATHETER OR BOTH CAUSED THE PERFORATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade; Perforation of Vessels

  MAUDE report 15130426 ↗
• InjuryJan 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING LEFT VENTRICULAR (LV) LEAD IMPLANT, AS THE PHYSICIAN WAS ATTEMPTED TO ENTER THE TARGET LV VEIN, A PERFORATION WITH PERICARDIAL EFFUSION OCCURRED. CONTRAST WAS USED TO IDENTIFY THE PERFORATION. THE PLACEMENT WAS ABANDONED. AN EMERGENCY ECHOCARDIGRAM WAS OBTAINED WITH A PERICARDIAL TAP PROCEDURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 13225962 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANT, THE PATIENT'S CORONARY SINUS WAS DISSECTED DURING CORONARY SINUS ACCESS. THE CATHETER WAS REMOVED AND THE LEFT VENTRICULAR (LV) LEAD PLACEMENT WAS ABANDONED. THE PHYSICIAN CHOSE TO PLACE THE LV LEAD INTO THE LV PORT AND COIL THE LEAD IN THE POCKET. THE PATIENT WOULD RETURN AT A LATER DATE TO PLACE THAT LV LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 11797557 ↗