Attain Command™ + SureValve™ 6250V-EH (UDI 00643169142886)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169142886), received between Aug 9, 2017 and May 29, 2020 — classified as 1 death, 5 injuries, 2 malfunctions.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2020Adverse 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 WAS OBSERVED DURING USE OF THE DELIVERY CATHETER. THE DELIVERY CATHETER WAS REMOVED AND THE IMPLANT PROCEDURE WAS ABANDONED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 10102157 ↗
• DeathFeb 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT PRIOR TO THE IMPLANT PROCEDURE THE PATIENT WAS SICK BUT IN STABLE CONDITION AND HAD BEEN RECEIVING TEMPORARY PACING SUPPORT. NO COMPLICATIONS OCCURRED DURING THE IMPLANT AND THE CAUSE OF DEATH IS NOT KNOWN.

  Patient problems: Death

  MAUDE report 9666693 ↗
• MalfunctionDec 17, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE AND PRIOR TO USE WITH THE PATIENT, A SMALL FIBER WAS OBSERVED AT THE HUB AT THE DELIVERY CATHETER. THE SCRUB NURSE NOTED THE FIBER LOOKED LIKE A HAIR; THE CATHETER WAS NOT UTILIZED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9481867 ↗
• InjurySep 19, 2019Adverse 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 THE PHYSICIAN WAS ABLE TO PLACE A GUIDE WIRE, HOWEVER, WHEN THE PHYSICIAN INTRODUCED THE CATHETER, THE CATHETER WAS UNABLE TO ADVANCE PAST THE BRACHIOCEPHALIC VEIN AND SUBCLAVIAN VEIN JUNCTION. THE PHYSICIAN TRIED TWO OTHER SHEATHS WITH THE SAME RESULT. THE PHYSICIAN THEN INJECTED CONTRAST AND IT STAYED IN THE MEDIASTINUM REGION AND DID NOT DISSIPATE FOR A FEW MINUTES. IT WAS NOTED THERE WAS AN UNCONFIRMED DISSECTION OF THE BRACHIOCEPHALIC VEIN. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS ADMITTED FOR OBSERVATION. A PIN PLUG WAS PLACED INTO THE LEFT VENTRICULAR (LV) LEAD PORT OF THE DEVICE AND THE PATIENT WAS REFERRED TO A CARDIOVASCULAR SURGEON FOR AN LV EPICARDIAL LEAD PLACEMENT IN THE FUTURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 9087962 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT¿S SPOUSE THAT THE PATIENT WENT INTO SURGERY TO FOR A GENERATOR UPGRADE AND THE SURGERY TOOK TWICE AS LONG AS EXPECTED. THE PATIENT¿S SPOUSE WAS TOLD THAT THEY WERE UNABLE TO DO THREE WIRES AS THE PATIENT¿S VEIN WAS DAMAGED, AND THEREFORE ONLY DID TWO WIRES. THE PATIENT¿S SPOUSE ALSO STATED THAT THEY WERE TOLD FROM THE SURGEON THAT THE CAT (CHLORAMPHENICOL ACETYL TRANSFERASE) SCAN SHOWED THAT IT WAS NOT AS BAD AS THEY THOUGHT AND THE PATIENT WOULD BE OKAY. FOLLOW-UP INFORMATION WAS OBTAINED AND IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO CANNULATE THE CS (CORONARY SINUS). THE PHYSICIAN WAS UNABLE TO PASS THE GUIDEWIRE WIRE INTO THE IVC (INFERIOR VENA CAVA) AND COULD NOT ADVANCE THE SHEATH. AFTER MULTIPLE ATTEMPTS TO PASS, CONTRAST WAS INJECTED TO DETERMINE WHY. IT WAS FOUND TO BE A POSSIBLE SMALL DISSECTION OF THE SVC (SUPERIOR VENA CAVA). THE CASE WAS THEN DOWNGRADED FROM A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TO A DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). AN ECHO WAS PERFORMED IN THE LAB AND NO PERICARDIAL EFFUSION WAS DETECTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 8758182 ↗
• MalfunctionDec 7, 2017Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CATHETER HUB PRESENTED MORE DIFFICULTY THAN USUAL WHEN SLITTING THE CATHETER, RESULTING IN THE PHYSICIAN TO FEEL LIKE THERE MIGHT BE AN ISSUE WITH THE HUB. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7092065 ↗
• InjuryOct 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CORONARY SINUS OR VENOUS DISSECTION OCCURRED WHILE ADVANCING THE DELIVERY CATHETER AND THE PATIENT'S BLOOD PRESSURE HAD DROPPED. NO EFFUSION WAS NOTED. THE PATIENT RECEIVED FLUIDS AND BLOOD PRESSURE AND PULSE THEN STABILIZED. THE LEAD IMPLANT WAS ABANDONED. THE PATIENT IS A PARTICIPANT IN THE WORLD-WIDE RANDOMIZED ANTIBIOTIC ENVELOPE INFECTION PREVENTION TRIAL CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 6924985 ↗
• InjuryAug 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UPGRADE PROCEDURE, THE PHYSICIAN CANNULATED THE CORONARY SINUS OSTIUM WITH THE DELIVERY CATHETER AND GUIDEWIRE AND ADVANCED THE CATHETER INTO WHAT WAS BELIEVED TO BE THE CORONARY SINUS BRANCH. CONTRAST WAS INJECTED AND THE CONTRAST FILLED THE PERICARDIAL CAVITY BUT THERE WAS NO STAINING NOTED. THE PATIENT THEN BECAME UNRESPONSIVE AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED FOR APPROXIMATELY 30 SECONDS AND THE PATIENT THEN BECAME RESPONSIVE. CPR WAS STOPPED AND AN ECHOCARDIOGRAM WAS PERFORMED, WHICH SHOWED A FIVE TO TEN PERCENT EFFUSION AND A PERFORATION OF PERICARDIUM WAS NOTED. THE DELIVERY CATHETER WAS REMOVED AND THE PHYSICIAN CHOSE TO IMPLANT A RIGHT VENTRICULAR (RV) LEAD AND CONNECT IT TO THE DEVICE WITH A PLUGGED LV PORT FOR A FUTURE IMPLANT TO ATTEMPT AN EPICARDIAL LV LEAD IMPLANT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest; Perforation; Pericardial Effusion

  MAUDE report 6780402 ↗