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Attain Select™ II + SureValve™ 6248V-90P (UDI 00763000160562)Recalls & reported problems

Medtronic, Inc. · CATHETER 6248V-90P ATTAIN SELECT II · Class 2

All models of Attain Select II + SureValve (15)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000160562), received between Sep 30, 2022 and Jan 10, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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

Device problems

  • Break2
  • Difficult to Flush1
  • Mechanical Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 10, 2023Break; Break

    IT WAS REPORTED THAT THE SHEATH BROKE DURING SLITTING AND THE ATTEMPTED LEFT VENTRICULAR (LV) LEAD DISLODGED. THE LEAD WAS REMOVED AS THE PHYSICIAN FELT THAT THE LEAD'S ACTIVE FIXATION MECHANISM WAS COMPROMISED. A NEW LEAD WAS PLACED WITH A NEW SHEATH BUT THE SHEATH BROKE DURING SLITTING AS THE FIRST ONE DID. THE LEAD WAS STILL IN POSITION. THE REMAINDER OF THE SHEATH WAS SLIT AWAY AND THE 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 16132386 ↗
  • MalfunctionJan 10, 2023Break; Break

    IT WAS REPORTED THAT THE SHEATH BROKE DURING SLITTING AND THE ATTEMPTED LEFT VENTRICULAR (LV) LEAD DISLODGED. THE LEAD WAS REMOVED AS THE PHYSICIAN FELT THAT THE LEAD'S ACTIVE FIXATION MECHANISM WAS COMPROMISED. A NEW LEAD WAS PLACED WITH A NEW SHEATH BUT THE SHEATH BROKE DURING SLITTING AS THE FIRST ONE DID. THE LEAD WAS STILL IN POSITION. THE REMAINDER OF THE SHEATH WAS SLIT AWAY AND THE 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 16132381 ↗
  • MalfunctionSep 30, 2022Difficult to Flush; Mechanical Problem; Difficult to Flush; Mechanical Problem

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THERE WAS INCREASED DIFFICULTY FLUSHING AND SLITTING THE CATHETER SHEATH. THE IMPLANT WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15510738 ↗

Other Catheter, percutaneous devices

All Catheter, percutaneous devices →

Sources and updates

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