Attain Select™ II + SureValve™ 6248V-130P (UDI 00643169184183)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169184183), received between Dec 7, 2017 and Jul 13, 2022 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2022Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE A GUIDEWIRE BECAME STUCK IN THE LEFT VENTRICULAR (LV) LEAD LUMEN. THE CATHETER BROKE OFF NEAR THE HUB WHILE SLITTING. THE CATHETER WAS REMOVED USING A SCISSORS AND THE LV LEAD WAS REMOVED AND A NEW LV LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15004103 ↗
• MalfunctionJun 22, 2020Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE A PIECE OF THE CATHETER SLICED FREE AND SEPARATED FROM THE MAIN BODY OF THE CATHETER WHILE SLITTING. THE CATHETER WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10181931 ↗
• MalfunctionJan 7, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PHYSICIAN HAD EXTREME DIFFICULTY SLITTING THE DELIVERY CATHETER, MORE SPECIFICALLY GETTING THE SLITTER TO MOVE THROUGH THE HUB OF THE CATHETER. THE HUB APPEARED TO BE OUT OF ALIGNMENT. EVENTUALLY THE SLITTER DID WORK THROUGH THE HUB BUT A TREMENDOUS AMOUNT OF FORCE HAD TO BE APPLIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9558141 ↗
• MalfunctionDec 16, 2019Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT THE SUBSELECTOR HANDLE OF THE CATHETER BROKE OFF BEFORE SLITTING. THE INNER WIRE BROKE AS WELL. THE PHYSICIAN THEN HAD DIFFICULTY SLITTING AFTER PLACING THE LEFT VENTRICULAR (LV) LEAD SINCE THERE WAS NOTHING TO PULL THE SUBSELECTOR WITH TO SLIT. THE BROKEN SUBSELECTOR WAS REMOVED WITHOUT HAVING TO REMOVE THE LEAD AND SUBSELECTOR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9474865 ↗
• MalfunctionNov 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE VALVE OF THE CATHETER BECAME DETACHED WHEN SLITTING THE CATHETER. THE CATHETER WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9310699 ↗
• MalfunctionOct 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE HUB OF THE DELIVERY CATHETER PULLED AWAY FROM CATHETER BODY DURING THE SPITTING PROCESS. THE CATHETER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9226461 ↗
• MalfunctionOct 23, 2019Break; Break

  IT WAS REPORTED THAT THAT, DURING SLITTING, THE CATHETER SHEATH BROKE ABOUT FOUR INCHES FROM THE HANDLE. THE CATHETER WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9224354 ↗
• MalfunctionSep 16, 2019Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, DURING SLITTING OF THE SHEATH, THE DELIVERY CATHETER BROKE IN HALF TWICE. IT WAS NOTED THE CATHETER BROKE PERPENDICULAR TO THE ANGLE THE PHYSICIAN WAS SLITTING AT AND THE CATHETER WAS DIFFICULT TO REMOVE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9070121 ↗
• MalfunctionJun 21, 2019Break; Break

  IT WAS REPORTED THAT PRIOR TO IMPLANT PROCEDURE, THE PHYSICIAN WAS UNABLE TO FLUSH CATHETER WITHOUT A LOT OF FORCE. A DIFFERENT FLUSHING TOOL AND WAS STILL THE SAME UNABLE TO FLUSH PROPERLY. A DIFFERENT CATHETER WAS USED. IT WAS ALSO REPORTED WHEN CATHETER WAS SLIT WITH UNIVERSAL SLITTER, A SMALL HAIR LIKE RIBBON OF PLASTIC CAME OFF OF CATHETER. THE CATHETER WAS NOT USED. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8722593 ↗
• MalfunctionOct 29, 2018Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CATHETER BROKE IN HALF WHILE SLITTING. THE CATHETER WAS REPLACED AND PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8017327 ↗
• InjuryOct 1, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PATIENT EXPERIENCED A PERFORATION OF THE CORONARY SINUS. IT WAS NOTED THAT THE INJURY CORRECTED ITSELF WITH NO INTERVENTION. IT WAS ALSO NOTED THAT THE PHYSICIAN COMPLAINED OF ¿TIP STIFFNESS¿ OF THE CATHETER. THE CATHETER WAS NOT USED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Perforation

  MAUDE report 7923425 ↗
• MalfunctionFeb 8, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING IMPLANT, THE CATHETER BROKE JUST BEYOND THE HUB WHEN ATTEMPTING TO SLIT. THE PHYSICIAN NEEDED TO USE A SCALPEL TO INITIATE ANOTHER SLIT AND THEN USED A UNIVERSAL SLITTER TO COMPLETE THE TASK. THE CATHETER WAS REMOVED FROM USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7254075 ↗
• MalfunctionDec 7, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE VALVE END OF THE CATHETER BROKE OFF DURING SLITTING. THE PHYSICIAN HAD TO USE SMALL FORCEPS TO GRAB ONTO THE CATHETER TO CONTINUE SLITTING. THE PHYSICIAN WAS ABLE TO REMOVE THE BROKEN CATHETER WITH NO INJURY TO THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7094522 ↗