Ensemble™ ll ENS1022Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169713901), received between Nov 17, 2021 and Mar 30, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Material Rupture; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER PULMONIC VALVE, IT WAS NOTED THAT THERE WERE 3 SEPARATE DEPLOYMENT ATTEMPTS DUE TO DIFFICULTIES WITH DEPLOYING THE VALVE. IT WAS ALSO NOTED THAT THE OUTER BALLOON BURST DURING THE ATTEMPTED IMPLANT OF THE VALVE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715861 ↗
• MalfunctionNov 6, 2024Deformation Due to Compressive Stress; Activation Failure; Deformation Due to Compressive Stress; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE, THE DELIVERY CATHETER SYSTEM (DCS) COULD NOT UNSHEATHE TO DEPLOY THE VALVE. THIS OCCURRED PRIOR TO VALVE DEPLOYMENT. THE DCS WAS WITHDRAWN FROM THE PATIENT, A KINK WAS THEN OBSERVED ON THE DCS. A NEW DCS WAS USED FOR THE PROCEDURE. OF NOTE, THE PATIENT'S RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) WAS SOMEWHAT TORTUOUS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20623020 ↗
• MalfunctionFeb 28, 2022Material Rupture; Material Rupture

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, THE OUTER BALLOON ON THE DELIVERY CATHETER SYSTEM (DCS) BURST, PRIOR TO THE COMPLETE EXPANSION OR DEPLOYMENT OF THE VALVE. THE VALVE WAS RECAPTURED AND REMOVED FROM THE PATIENT. A NEW TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE WAS ULTIMATELY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13618666 ↗
• InjuryNov 17, 2021Material Separation; Failure to Advance; Deformation Due to Compressive Stress; Patient Device Interaction Problem; Material Separation; Failure to Advance; Deformation Due to Compressive Stress; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE DELIVERY CATHETER SYSTEM (DCS) WAS TOO BIG FOR THE VESSEL. THE DCS BECAME KINKED TRYING TO ADVANCE THROUGH THE CURVE INTO THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT). THE VALVE WAS UNABLE TO BE IMPLANTED. A VASCULAR INJURY DUE TO THE SMALL VESSEL WAS REPORTED. THE INJURY WAS TREATED WITH A COVERED STENT. THE PROCEDURE WAS ABORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Tissue Injury; Vascular Dissection

  MAUDE report 12828444 ↗