EnVeo™ R ENVEOR-US (UDI 00643169800915)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169800915), received between Feb 5, 2018 and Jul 5, 2018 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).

4 other recalls cover devices cleared under the same FDA submission (P130021); they may or may not involve this specific model.

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.

• InjuryJul 5, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, UPON REMOVAL OF THE DELIVERY CATHETER SYSTEM (DCS) THE NOSE CONE CAUGHT THE BOTTOM OF THE VALVE AND THE VALVE EMBOLIZED TO THE ASCENDING AORTA. IT WAS REPORTED THAT WHEN THE NON-MEDTRONIC GUIDEWIRE WAS PULLED BACK INTO THE NOSE CONE, IT LIKELY LEFT THE NOSE CONE STIFF CAUSING IT TO BECOME CAUGHT ON THE INNER EDGE OF THE INFLOW OF THE VALVE. A SECOND VALVE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7664940 ↗
• InjuryMay 30, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, WHILE THE VALVE WAS BEING RECAPTURED THE NOSECONE MADE CONTACT WITH ONE OF THE PADDLES AND THE VALVE DISLODGED ABOVE THE ANNULAR PLANE. SUBSEQUENTLY, A SECOND TRANSCATHETER BIOPROSTHETIC VALVE WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7554232 ↗
• DeathMay 25, 2018Perivalvular Leak; Positioning Problem; Perivalvular Leak; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, INTO AN EXISTING MEDTRONIC AORTIC ROOT BIOPROSTHESIS WITH SEVERE CENTRAL AORTIC REGURGITATION (AR), VASCULAR ACCESS WAS CHALLENGING DUE TO STENTS IN BOTH THE LEFT AND RIGHT ILIAC ARTERIES THAT EXTENDED DOWN INTO THE COMMON FEMORAL ARTERIES. RESISTANCE WAS NOTED WHEN INSERTING AND ADVANCING THE DILATORS AND SHEATH. NO LARGER THAN A 4 FRENCH PIGTAIL CATHETER COULD BE INSERTED INTO THE LEFT SIDE. THE RIGHT SIDE WAS DEEMED ADEQUATE, BUT HAD TO BE DILATED EXTENSIVELY TO ACCOMMODATE A 14 FRENCH SHEATH. THE 14 FRENCH NON-MEDTRONIC SHEATH WAS INSERTED DURING DEVICE PREPARATION AND THEN REMOVED TO INTRODUCE THE DELIVERY CATHETER SYSTEM USING THE INLINE SHEATH. DEPLOYMENT WAS ATTEMPTED, BUT THE VALVE WAS RECAPTURED THREE TIMES FOR REPOSITIONING. AFTER THE THIRD FAILED ATTEMPT, THE VALVE WAS REMOVED FROM THE PATIENT AND NOT IMPLANTED. SUBSEQUENTLY, A SECOND VALVE AND SECOND DELIVERY CATHETER SYSTEM (DCS) WERE PREPPED AND INSERTED. THE VALVE WAS DEPLOYED AND RECAPTURED TWICE DUE TO REPOSITIONING. THE THIRD DEPLOYMENT ATTEMPT WAS SUCCESSFUL AND THE VALVE WAS IMPLANTED. HEMODYNAMICS STARTED TO IMP

  Patient problems: Death; Low Blood Pressure/ Hypotension; Perforation

  MAUDE report 7545134 ↗
• InjuryMay 7, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, WHILE RETRACTING THE NOSE CONE OF THE DELIVERY CATHETER SYSTEM (DCS), THE NOSE CONE CAUSED THE VALVE TO DISLODGE. SUBSEQUENTLY, A SECOND TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7489918 ↗
• MalfunctionFeb 5, 2018Break; Positioning Failure; Device Dislodged or Dislocated; Positioning Problem; Break; Positioning Failure; Device Dislodged or Dislocated; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS POSITIONED ABOVE THE ANNULUS. DURING REMOVAL OF THE DELIVERY CATHETER SYSTEM (DCS), THE NOSE CONE OF THE DCS BECAME STUCK IN THE VALVE STRUTS AND DISLODGED THE VALVE INTO THE ASCENDING AORTA. A SECOND TRANSCATHETER BIOPROSTHETIC VALVE WAS ATTEMPTED TO BE IMPLANTED VALVE-IN-VALVE WITH TH IS SECOND DCS. DURING DEPLOYMENT OF THE SECOND VALVE, TENSION WAS FELT AND THE VALVE DISLODGED UPWARD. FOLLOWING RECAPTURE OF THE VALVE, THE HANDLE OF THE DCS WAS SPINNING AND UNABLE TO REDEPLOY THE VALVE. THE CAPSULE OF THE SECOND DCS WAS BROKEN. THE SECOND VALVE AND THE SECOND DCS WERE WITHDRAWN FROM THE BODY. UPON DIRECT VISUALIZATION, THE VALVE WAS UNABLE TO BE REMOVED FROM THE DCS AND A CAPSULE BREAK WAS NOTED NEAR THE INLINE SHEATH. ANOTHER TRANSCATHETER BIOPROSTHETIC VALVE, WAS THEN SUCCESSFULLY IMPLANTED IN THE AORTIC ANNULUS WITH A THIRD DCS. THE PATIENT WAS REPORTED TO BE STABLE AFTER SUCCESSFUL VALVE IMPLANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7241613 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P130021. One submission often covers many models, so check the product and lot details in each record.

• Z-0561-2021 · Oct 23, 2020 · Terminated
  Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS-23 COMM US; b. EVPROPLUS-26US, Labeled as
• Z-0560-2021 · Oct 23, 2020 · Terminated
  Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 29L OUS, VLV EVOLUTPRO-23 BLUE 29L COMM OUS, VLV EVOLUTPRO-23 B
• Z-0559-2021 · Oct 23, 2020 · Terminated
  Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV CE
• Z-2264-2015 · Jul 15, 2015 · Terminated
  EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evol