Attain Select™ II + SureValve™ 6248V-90L (UDI 00643169143180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169143180), received between Dec 7, 2017 and Jan 18, 2019 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE CATHETER BROKE IN HALF WHILE BEING SPLIT. 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 8262450 ↗
• MalfunctionJan 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER BROKE IN HALF WHILE ATTEMPTING TO SPLIT. 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 8252764 ↗
• MalfunctionApr 10, 2018Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, UPON SLITTING THE SHEATH, THE SHEATH BROKE ABOUT 4 TO 5 CM FROM THE PROXIMAL END. THE PHYSICIAN HAD TO REENGAGE MANUALLY TO FINISH SPLITTING THE SHEATH. THE SHEATH WAS ATTEMPTED AND NOT USED. ANOTHER SHEATH WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7418827 ↗
• MalfunctionApr 10, 2018Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, UPON SLITTING THE CATHETER THE PROXIMAL END OF THE SHEATH BROKE AND HAD TO BE MANUALLY REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7418378 ↗
• MalfunctionApr 10, 2018Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THERE WAS NO SENSING ON THE RIGHT ATRIAL (RA) LEAD. THE LEAD WAS ATTEMPTED AND NOT USED. ANOTHER LEAD WAS USED. IT WAS ALSO REPORTED UPON SLITTING THE PHYSICIAN LOST THE SLITTER ENGAGEMENT OF THE CATHETER. WHEN RE-ENGAGING THE SLITTER AND ATTEMPTING TO SLIT THE CATHETER PORTION CONTAINING THE HUB SLIT OFF AND THERE WAS NO "HANDLE" LEFT TO PULL ON THE CATHETER. ANOTHER CATHETER WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7416316 ↗
• MalfunctionFeb 8, 2018Detachment Of Device Component; Material Fragmentation; Detachment Of Device Component; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE CATHETER FELL OFF WHILE WIPING THE CATHETER. THE CATHETER WAS NOT USED IN A PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7254597 ↗
• MalfunctionDec 7, 2017Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CATHETER CAME APART DURING SLITTING. THE CATHETER SNAPPED APART ABOUT FIVE INCHES DISTAL TO THE VALVE WHEN THE SLITTER REACHED THAT POINT. THE PHYSICIAN GRASPED THE TORN EDGE OF THE CATHETER WITH FORCEPS AND CONTINUED SLITTING TO SUCCESSFULLY REMOVE THE CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7094350 ↗