Attain Select™ II + SureValve™ 6248V-90S (UDI 00643169143197)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169143197), received between Oct 6, 2017 and Nov 19, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2019Mechanical Problem; Detachment of Device or Device Component; Material Integrity Problem; Mechanical Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN WAS ATTEMPTING TO PLACE THE LEFT VENTRICULAR (LV) LEAD WHEN THE CATHETER WAS UNABLE TO BE ADVANCED DUE TO PATIENT ANATOMY. THE PHYSICIAN ATTEMPTED TO SLIT THE INNER CATHETER BUT WAS NOT ABLE TO SLIT ALL THE WAY THROUGH THE WHITE HUB. THE TIP OF THE CATHETER BROKE OFF. NO LV LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9341897 ↗
• MalfunctionAug 5, 2019Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING IMPLANT THE CATHETER BROKE DURING SLITTING AND REMOVAL. 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 8862248 ↗
• MalfunctionMar 22, 2019Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE REPLACEMENT PROCEDURE, THE INNER CATHETER BROKEN IN HALF AND THE LEFT VENTRICULAR (LV) LEAD DISLODGED WHEN SLITTING THE CATHETER. THE LEAD AND THE CATHETER WERE NOT USED, AND ANOTHER LV LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8445152 ↗
• MalfunctionJun 1, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT WHILE SLITTING THE INNER CATHETER BROKE. THE CATHETER WAS ABLE TO BE REMOVED WITH THE LEAD INTACT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7560317 ↗
• MalfunctionOct 6, 2017Break; Detachment Of Device Component; Material Fragmentation; Device Or Device Fragments Location Unknown; Break; Detachment Of Device Component; Material Fragmentation; Device Or Device Fragments Location Unknown

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE WHEN THE PHYSICIAN STARTED TO SLIT THE CATHETER, THE HUB AND PART OF THE PROXIMAL CATHETER TOTALLY SEPARATED AND DETACHED FROM THE REMAINING BODY OF THE CATHETER. THE PHYSICIAN WAS REQUIRED TO CUT AWAY THE REMAINING CATHETER WITH IRIS SCISSORS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6920978 ↗