Ensemble™ ll ENS1018Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169713888), received between Aug 21, 2024 and Aug 21, 2024 — classified as 1 malfunction.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE ATTEMPTED IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE, A PRE-IMPLANT BALLOON DILATATION WAS PERFORMED AS A STANDARD FOR THE IMPLANTING PHYSICIAN. THE DELIVERY CATHETER SYSTEM WAS INSERTED INTO THE PATIENT WITHOUT A VALVE LOADED FOR A PRE-IMPLANT STENT PLACEMENT. UPON WITHDRAWAL OF THE SYSTEM, IT WAS NOTED THAT THE HEMOSTASIS SLEEVE WAS OVER THE BACK END OF THE SHEATH, CAUSING THE OUTER SHEATH TO BE COMPRESSED. A VALVE WAS NOT LOADED INTO THE DELIVERY SYSTEM UPON NOTICING THE COMPRESSION. SUBSEQUENTLY, A NEW DELIVERY SYSTEM WAS USED TO SUCCESSFULLY IMPLANT THE VALVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20015471 ↗