EnVeo RRecalls & reported problems across all models
Medtronic Corevalve LLC · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 140
- Deaths reported
- 21
- Injuries reported
- 52
- Recalls
- 0
We found 5 models of EnVeo R by Medtronic Corevalve LLC in the FDA's device registry (GUDID). Together they are named in 140 adverse event reports in the FDA's MAUDE database, received between Dec 7, 2016 and Jul 10, 2025 — classified as 21 deaths, 52 injuries, 67 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (58 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported EnVeo R problems
Device problems
- Detachment of Device or Device Component58
- Device Dislodged or Dislocated25
- Difficult to Advance18
- Adverse Event Without Identified Device or Use Problem15
- Device Difficult to Setup or Prepare15
- Positioning Problem15
- Difficult or Delayed Positioning11
- Failure to Advance8
Patient problems
- No Clinical Signs, Symptoms or Conditions44
- No Known Impact Or Consequence To Patient35
- Low Blood Pressure/ Hypotension24
- Death20
- Vascular Dissection20
- Perforation11
- Calcium Deposits/Calcification10
- Pericardial Effusion8
EnVeo R models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EnVeo™ R ENVEOR-USAortic valve, prosthesis, percutaneously delivered5 deaths58 reports
- EnVeo™ R ENVEOR-N-USAortic valve, prosthesis, percutaneously delivered4 deaths34 reports
- EnVeo™ R ENVEOR-N-USAortic valve, prosthesis, percutaneously delivered8 deaths28 reports
- EnVeo™ R ENVEOR-N-USAortic valve, prosthesis, percutaneously delivered3 deaths15 reports
- EnVeo™ R ENVEOR-USAortic valve, prosthesis, percutaneously delivered1 death5 reports
Recent EnVeo R adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2025Peeled/Delaminated; Detachment of Device or Device Component; Material Deformation; Peeled/Delaminated; Detachment of Device or Device Component; Material Deformation
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE APPEARED CONSTRAINED AND UNDER-EXPANDED. THE VALVE WAS RECAPTURED AND DURING THE SECOND DEPLOYMENT OF THE VALVE, IT WAS NOTED THAT THE VALVE APPEARED CONSTRAINED. IT WAS DECIDED TO RECAPTURE THE VALVE AND TO PERFORM A BALLOON AORTIC VALVULOPLASTY (BAV). HOWEVER, UPON RECAPTURING THE VALVE AT ABOUT 60%, THE BLUE HANDLE OF THE DELIVERY CATHETER SYSTEM (DCS) BROKE INTO TWO PARTS. THE HANDLE WAS MANUALLY PUT BACK TOGETHER AND THE VALVE WAS RECAPTURED AND REMOVED FROM THE PATIENT. IT WAS REPORTED THAT NO TENSION WAS FELT IN THE SYSTEM. A NEW VALVE AND DCS WERE USED FOR IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22473138 ↗MalfunctionJul 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE DELIVERY CATHETER SYSTEM (DCS) CAPSULE WAS INTENTIONALLY OVER-DRIVEN IN ORDER TO NAVIGATE THE UNFAVORABLE ANGLE OF THE PATIENT ANATOMY. THE DCS WAS HUGGING THE LESSER CURVE AND DID NOT LINE UP CORRECTLY WITH THE ANNULAR PLANE. AFTER THREE RECAPTURES AND AFTER THE DCS HAD BEEN OVER-DRIVEN TWICE, THE ACTUATOR HANDLE SEPARATED DURING ATTEMPTED DEPLOYMENT. THE VALVE WAS RECAPTURED AND THE SYSTEM WAS REMOVED. A NEW DCS WAS USED FOR SUCCESSFUL IMPLANT. THERE WAS NOT A LOOSE TAB PRESENT IN THE PACKAGING AND BOTH KNOBS WERE INTACT. IT WAS NOTED THAT THE LOADER WAS EXPERIENCED. NO ADDITIONAL DAMAGE WAS NOTED ON THE DEPLOYMENT KNOB. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22385331 ↗MalfunctionJul 1, 2025Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component
MEDTRONIC RECEIVED INFORMATION THAT DURING THE LOADING OF A 29 PRO TRANSCATHETER BIOPROSTHETIC VALVE WITH THIS DELIVERY CATHETER SYSTEM (DCS), DURING OVERDRIVE THE DEPLOYMENT KNOB, ON THE DCS HANDLE SEPARATED. NO UNUSUAL RESISTANCE WAS FELT DURING THE LOADING OF THE VALVE. THE DCS WAS REPLACED AND THE VALVE WAS LOADED SUCCESSFULLY. NO PATIENT INVOLVEMENT WAS REPORTED WITH THE DCS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22372075 ↗MalfunctionJul 1, 2025Detachment of Device or Device Component; Activation Failure; Detachment of Device or Device Component; Activation Failure
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS CROSSED AND DEPLOYMENT HAD BEGUN WITH NORMAL TURNING OF THE DELIVERY CATHETER SYSTEM (DCS) DEPLOYMENT KNOB. WHILE TURNING THE KNOB, THE DEPLOYMENT KNOB BROKE. THE DCS WAS ABLE TO BE PULLED OUT OF THE PATIENT. A NEW DCS WAS USED FOR IMPLANT. IT WAS REPORTED THAT THE VALVE WAS LOADED ONCE PRIOR TO FLUORO CHECK AND THE DEPLOYMENT HANDLE ROTATED FINE DURING LOADING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22371429 ↗MalfunctionJul 1, 2025Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component
MEDTRONIC RECEIVED INFORMATION THAT WHEN REMOVING THIS DELIVERY CATHETER SYSTEM (DCS) FROM ITS CONTAINER, IT WAS NOTICED THAT THE HANDLE HAD COME APART AND WAS NOT ASSEMBLED. THE HANDLE WAS NOT CRIMPED ON TIGHTLY. NO SMALL PIECES WERE NOTED IN THE TRAY. ANOTHER DCS WAS USED FOR THE IMPLANT. NO PATIENT INVOLVEMENT WAS REPORTED WITH THE BROKEN DCS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22371062 ↗MalfunctionJun 30, 2025Difficult or Delayed Positioning; Peeled/Delaminated; Detachment of Device or Device Component; Difficult or Delayed Positioning; Peeled/Delaminated; Detachment of Device or Device Component
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS 80% DEPLOYED AND IT WAS REPORTED THE VALVE WAS SHALLOW. WHILE RECAPTURING THE VALVE, A "POP" SOUND WAS HEARD. THE VALVE WAS COMPLETELY RECAPTURED AND THE BLUE HANDLE FELL APART ON THE DELIVERY CATHETER SYSTEM (DCS). THE DCS AND VALVE WERE REMOVED AND A NEW VALVE AND DCS WERE USED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22360703 ↗MalfunctionJun 30, 2025Difficult or Delayed Positioning; Difficult or Delayed Activation; Detachment of Device or Device Component; Difficult or Delayed Positioning; Difficult or Delayed Activation; Detachment of Device or Device Component
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF A 29MM TRANSCATHETER BIOPROSTHETIC VALVE, WAS LOADED ON THE DELIVERY CATHETER SYSTEM¿S (DCS). A FLUOROSCOPY CHECK CONFIRMED A GOOD LOAD. THE VALVE WAS THEN DEPLOYED TOO DEEP AND WAS RECAPTURED. DURING REDEPLOYMENT OF THE VALVE, THE BLUE DEPLOYMENT KNOB SEPARATED INTO TWO PIECES AND FELL APART FROM THE DCS. THE OPERATOR HAD TO MANUALLY ASSEMBLE THE DEPLOYMENT KNOB AND MOUNT IT BACK ON THE DCS. THE DEPLOYMENT WAS COMPLETED SUCCESSFULLY, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22359678 ↗MalfunctionJun 30, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation
MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS 11 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVED CONDUIT, THE VALVE WAS REPLACED VALVE-IN-VALVE WITH A MEDTRONIC TRANSCATHETER VALVE DUE TO MODERATE CENTRAL REGURGITATION. DURING IMPLANT OF THE FIRST TRANSCATHETER VALVE, THE VALVE DISLODGED ABOVE THE ANNULUS RESULTING IN SEVERE PARAVALVULAR LEAK (PVL). THE VALVE REMAINS IN THE PATIENT. A SECOND TRANSCATHETER VALVE WAS IMPLANTED. DURING LOADING OF THE SECOND VALVE, THE HANDLE OF THE DELIVERY CATHETER SYSTEM (DCS) CAME APART WHILE TURNING THE HANDLE. THE VALVE WAS UNLOADED AND SUCCESSFULLY LOADED ONTO A NEW DCS AND WAS SUCCESSFULLY IMPLANTED VALVE-IN-VALVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22358113 ↗MalfunctionJun 27, 2025Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, THE INITIAL INSPECTION OF THE DELIVERY CATHETER SYSTEM (DCS), PRIOR TO LOADING THE VALVE, IDENTIFIED THAT THE DCS¿S DEPLOYMENT KNOB ON THE HANDLE WAS SLIGHTLY SEPARATED. THE SLIGHT SEPARATION WAS OBSERVED BETWEEN THE SEAM OF THE DEPLOYMENT KNOB, LOCATED IN THE TAB AREA. THE KNOB WAS SLIGHTLY SQUEEZED, WITHOUT EXCESSIVE FORCE AND AN AUDIBLE ¿CLICK¿ WAS HEARD, CONFIRMING A SECURE ATTACHMENT OF THE HANDLE. AT ONE THIRD OF THE INITIAL LOAD, THE KNOB SEPARATED WITHIN THE FIRST ROTATION, WHILE ATTEMPTING TO CAPTURING THE VALVE. THE CAPSULE DID NOT REACH THE PADDLE ATTACHMENT BEFORE THE SEPARATION OCCURRED. THERE WAS NO PATIENT INVOLVEMENT WITH THE DCS AND ANOTHER DCS WAS USED FOR THE IMPLANT PROCEDURE. NOTE: THE DEPLOYMENT KNOW TRIGGER WAS UTILIZED WHEN THE CAPSULE WAS OPENED FOR FLUSHING. NO UNUSUAL TENSION WAS FELT IN THE SYSTEM DURING THE LOADING PROCEDURE AND NO ADDITIONAL DAMAGE OR MARKS WERE NOTED ON THE DEPLOYMENT KNOB. THE LOADER HAD PREVIOUSLY LOADED APPROXIMATELY 10 VALVES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22345327 ↗MalfunctionJun 27, 2025Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, WHILE LOADING THE VALVE AND THE CLEAR TUBE WAS REMOVED, IT WAS REPORTED THAT THE VALVE WAS MISLOADED. IT WAS NOTED THAT THE PADDLE WAS OUT OF POCKET. ON THE SECOND LOAD TURN, THE HANDLE FELL OFF. THE DELIVERY CATHETER SYSTEM (DCS) WAS NOT USED AND THE VALVE WAS LOADED ONTO A DIFFERENT DCS FOR IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22345207 ↗MalfunctionJun 27, 2025Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, DURING LOADING THE VALVE LOADING, THERE WAS GREATER THAN USUAL TENSION REPORTED WHILE TURNING THE DEPLOYMENT KNOB BEFORE COVERING THE PADDLES. THE TENSION REMAINED THE SAME AND THE DEPLOYMENT KNOB ALMOST SPLIT OPEN DURING THE LOADING. THE LOADING WAS ABORTED PRIOR TO THE KNOB BREAKING. NO END CAP SEPARATION OR MISLOAD WERE REPORTED. THE DELIVERY CATHETER SYSTEM (DCS) WAS NOT USED. A DIFFERENT DCS WAS USED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22345103 ↗MalfunctionJun 27, 2025Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, THE DELIVERY CATHETER SYSTEM (DCS) HANDLE SEPARATED INTO TWO PIECES WHILE ATTEMPTING TO LOAD THE VALVE. THE DCS WAS ¿SNAPPED¿ BACK TOGETHER, BUT WHEN ATTEMPTING TO CONTINUE TO LOADING VALVE INTO THE DCS THE BLUE HANDLE SEPARATED AGAIN. AT THIS TIME A SMALL PIECE OF THE BLUE HANDLE WAS SEEN IN THE BOTTOM OF THE TRAY AND THE VALVE WAS UNLOADED FROM THE DCS. A NEW DCS WAS USED TO LOAD AND IMPLANT THE VALVE. THE DCS HANDLE SEPARATION DID NOT CAUSE A DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22344782 ↗MalfunctionJun 26, 2025Difficult or Delayed Positioning; Detachment of Device or Device Component; Difficult or Delayed Positioning; Detachment of Device or Device Component
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, UPON RECAPTURING THE VALVE DUE TO A DEEP IMPLANT, THE BLUE HANDLE OF THE DELIVERY CATHETER SYSTEM (DCS) SEPARATED HALF WAY THROUGH THE RECAPTURE. THE PHYSICIAN WAS ABLE TO CLICK THE HANDLE BACK TOGETHER AND COMPLETE THE VALVE RECAPTURE. THE VALVE WAS SUCCESSFULLY DEPLOYED ON THE SECOND ATTEMPT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. OF NOTE, THE PATIENT HAS A MEDICAL HISTORY OF AORTIC STENOSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22341239 ↗MalfunctionJun 26, 2025Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS 34 MM TRANSCATHETER BIOPROSTHETIC VALVE, WHILE LOADING THE VALVE ONTO THE DELIVERY CATHETER SYSTEM (DCS), THE BLUE HANDLE SPLIT AT THE SEAM AND SEPARATED. SUBSEQUENTLY, THE DCS WAS NOT USED FOR THE IMPLANT AND WILL BE RETURNED FOR ANALYSIS. ANOTHER DCS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE LOADING WAS PERFORMED BY EXPERIENCED MEDTRONIC PERSONNEL AND NO EXCESS RESISTANCE WAS FELT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22340867 ↗MalfunctionJun 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS 26MM TRANSCATHETER BIOPROSTHETIC VALVE, WHEN THE CAPSULE OF THE DCS WAS CLOSED 2/3 DURING THE ATTEMPT TO LOAD THE VALVE INTO THE DELIVERY CATHETER SYSTEM (DCS), THE DEPLOYMENT KNOB SEPARATED. IT WAS REPORTED THE VALVE WAS LOADED BY A RELATIVELY NEW VALVE LOADER AND THE DEPLOYMENT KNOB TRIGGER WAS USED DURING BEFORE VALVE LOADING. THE HANDLE WAS NOT OVER-DRIVEN AT ANY POINT IN THE LOAD PROCESS AND NO UNUSUAL TENSION WAS FELT IN THE SYSTEM DURING LOADING. SUBSEQUENTLY, THE DCS WAS NOT USED FOR THE IMPLANT AND WILL BE RETURNED FOR ANALYSIS. ANOTHER DCS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22340798 ↗
Other Medtronic Corevalve LLC products
All Medtronic Corevalve LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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