Attain Select™ II + SureValve™ 6248V-90 (UDI 00763000160548)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00763000160548), received between Oct 11, 2021 and Jun 4, 2025 — classified as 1 death, 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2025Accessory Incompatible; Break; Mechanical Problem; Material Integrity Problem; Accessory Incompatible; Break; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, A FEW DIFFERENT CATHETERS WERE USED AS THERE WAS SLITTING DIFFICULTY THAT CAUSED THE LEFT VENTRICULAR (LV) LEAD TO DISLODGE. IT WAS NOTED THAT THE CATHETERS KEPT BREAKING AND THAT THE VALVES WERE VERY DIFFICULT TO PASS THROUGH. ONE OF THE CATHETERS BECAME STUCK IN THE VALVE DURING THE LEAD IMPLANT. A DIFFERENT LV LEAD WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144218 ↗
• MalfunctionMay 2, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THERE WAS SLITTING DIFFICULTY OF THE CATHETER. THE SLITTER CAME OUT THE SIDE OF THE CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21951286 ↗
• InjuryMar 12, 2025Adverse 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 ACCESSED THE PATIENT'S VEIN USING AN INNER CATHETER AND A GUIDEWIRE. IT WAS NOTED THAT THE GUIDEWIRE WENT TO AN UNEXPECTED LOCATION IN THE TARGET VEIN AND THE PHYSICIAN BELIEVED IT WAS A SUB-BRANCH INSIDE THE VEIN. A LEAD WAS THEN INTRODUCED AND DID NOT CAPTURE ON ANY VECTOR. WHEN THE PHYSICIAN WAS ¿FISHING¿ FOR A NEW BRANCH TO PLACE THE LEAD, THEY NOTICED THAT THE WIRE WAS NOT IN THE SAME VEIN. THE PHYSICIAN THEN ELECTED TO DO A PUFF OF CONTRACT AND SAW THE CONTRACT DIFFUSE. THE INNER CATHETER WAS REMOVED AND IT WAS OBSERVED THAT THE PATIENT¿S BLOOD PRESSURE HAD DROPPED AND THE PHYSICIAN DID AN EMERGENCY PERICARDIOCENTESIS WHICH WAS SUCCESSFUL. IT WAS NOTED THAT THE PHYSICIAN SUSPECTED THAT THE INNER CATHETER WAS THE CAUSE OF THE PERICARDIAL EFFUSION AND A PERFORATION WAS ALSO OBSERVED. THE OPERATION WAS THEN ABORTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 21587401 ↗
• MalfunctionJan 13, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE LEFT VENTRICULAR (LV) LEAD IMPLANT TWO DIFFERENT CATHETERS WERE USED. DURING THE FIRST ATTEMPT IT WAS NOTED THAT WHEN THE PHYSICIAN WENT TO SLIT THE CATHETER, THE HANDLE OF THE HUB BROKE OFF, PULLING THE CATHETER THROUGH THE SLITTER AND CAUSING THE SLITTER TO COME OFF THE RAIL THUS CAUSING THE LEAD TO GET TRAPPED IN THE CATHETER AND DISLODGING THE LEAD. DURING THE SECOND ATTEMPT IT WAS NOTED THAT THE HUB CATHETER BROKE OFF AGAIN NEARLY DISLODGING THE LEAD AGAIN HOWEVER THE LEAD WAS SUCCESSFULLY IMPLANTED. THE 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 21145525 ↗
• MalfunctionOct 12, 2024Break; Break

  IT WAS REPORTED THAT DURING THE REPLACEMENT PROCEDURE, THE WHOLE LUER HUB DETACHED FROM THE CATHETER WHILE TRYING TO SLIT. THE PHYSICIAN WAS ABLE TO SUCCESSFUL SLIT BY USING A HEMOSTAT TO HOLD THE SHEATH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20435207 ↗
• MalfunctionOct 6, 2024Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN TRIED TO SLIT THE CATHETER. THE CATHETER BODY COMPLETELY BROKE IN TWO PIECES NEAR THE LUER HUB. THE PHYSICIAN WAS ABLE TO CUT DOWN ON THE BODY AND SLIT. THE LEAD STAYED IN PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20380223 ↗
• 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 19802362 ↗
• MalfunctionDec 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE SHAFT OF THE CATHETER SEVERED IN HALF WHILE SLITTING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371228 ↗
• MalfunctionApr 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE WHITE HUB OF THE SUBSELECTOR BROKE OFF WHEN THE CATHETER WAS BEING SLIT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807443 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE WHEN PHYSICIAN WAS TRYING TO SUB-SELECT THE CANDIDATE BRANCH VEIN USING CATHETER AND DILATOR, PERICARDIAL EFFUSION WAS OBSERVED. THE EFFUSION WAS CONFIRMED USING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND BY INJECTING CONTRAST DYE FROM THE INNER CATHETER. THE PATIENT WAS WATCHED OVERNIGHT IN THE INTENSIVE CARE UNIT (ICU). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 15788378 ↗
• DeathAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THE LEFT VENTRICULAR (LV) LEAD AND USE OF THE CATHETER, IT WAS OBSERVED THAT THE GUIDEWIRE AND THE LEAD WERE ADVANCING DOWN A NON-VISUALIZED PATH ON THE VENOGRAM. A CORONARY SINUS DISSECTION HAD OCCURRED, THE PATIENT'S BLOOD PRESSURE WAS LOW, AND A CODE WAS CALLED. THE LEAD, THE CATHETER, THE SHEATH AND THE GUIDEWIRE WERE REMOVED IMMEDIATELY. PERICARDIAL EFFUSION AND TAMPONADE FROM THE PERFORATION WERE OBSERVED. PULSELESS ELECTRICAL ACTIVITY (PEA) WAS DIAGNOSED AND RESCUE ATTEMPTS WERE PERFORMED. THE PHYSICIAN PERFORMED A STERNOTOMY TO EVACUATE THE CAVITY AND REPAIR HEART. BLOOD AND FLUID WAS SUCCESSFULLY REMOVED TO RELIEVE TAMPONADE AND THE TEAR WAS SURGICALLY REPAIRED. THE PATIENT WAS GIVEN FOUR UNITS OF BLOOD. THE PATIENT WAS UNABLE TO BE RESUSCITATED AND PASSED AWAY.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Perforation; Pericardial Effusion; Vascular Dissection

  MAUDE report 15212273 ↗
• MalfunctionJul 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING IMPLANT, THE PROXIMAL HANDLE OF THE CATHETER BROKE OFF DURING SLITTING, THE VALVE WAS CINCHED DOWN ON THE CATHETER BODY, AND THE REMAINDER OF THE CATHETER WAS SLIT SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15027398 ↗
• MalfunctionMay 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING IMPLANT THE HEADER ON THE CATHETER SNAPPED OFF DURING SLITTING. THE CATHETER WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14338128 ↗
• MalfunctionNov 23, 2021Break; Break

  IT WAS REPORTED THAT DURING IMPLANT TWO CATHETERS BROKE WHILE SLITTING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860826 ↗
• MalfunctionOct 28, 2021Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE DELIVERY CATHETER VALVE WAS TIGHT, MAKING IT DIFFICULT TO EASILY PASS THE GUIDEWIRE, LEAD OR SLITTER THROUGH THE DISTAL HUB. DIFFICULTY ADVANCING THROUGH THE HUB WAS ALSO NOTED. THE CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712346 ↗
• MalfunctionOct 19, 2021Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER BROKE NEAR THE HUB DURING SLITTING. THE PHYSICIAN HAD TO GRASP THE REMAINDER OF THE CATHETER WITH A HEMOSTAT IN ORDER TO CONTINUE THE SLITTING. THE REMAINDER OF THE CATHETER WAS SUCCESSFULLY REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12656500 ↗
• MalfunctionOct 11, 2021Use of Device Problem; Use of Device Problem

  IT WAS FURTHER CONFIRMED THAT THE SAME CATHETER WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12606024 ↗