Attain Select™ II + SureValve™ 6248V-90SP (UDI 00763000160586)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000160586), received between Apr 10, 2023 and Jun 14, 2023 — classified as 2 malfunctions.

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

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE SUBSELECTOR EXHIBITED A POSSIBLE FAULTY SEALING RING LEADING TO AN INABILITY TO FLUSH THE SHEATH WITH THE ADAPTOR. THE SUBSELECTOR WAS NOT USED IN THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125797 ↗
• MalfunctionApr 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE WHEN ATTEMPTING TO SLIT THE CATHETER SUBSELECTOR AFTER THE LEAD WAS PLACED, THE HUB SNAPPED OFF. THE USER WAS UNABLE TO CONTINUE TO SLIT THE CATHETER WITHOUT THE HUB SO THE LEAD HAD TO BE REMOVED WITH THE SUBSELECTOR AROUND THE LEAD. THE LEAD WAS PLACED AGAIN WITH A DIFFERENT CATHETER IN A DIFFERENT BRANCH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709066 ↗