EnVeo PRORecalls & reported problems across all models

We found 2 models of EnVeo PRO by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 252 adverse event reports in the FDA's MAUDE database, received between Apr 24, 2018 and Jul 17, 2025 — classified as 27 deaths, 112 injuries, 113 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (78 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

EnVeo PRO recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 11, 2021Open, Classified

   Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

   Z-2042-2021 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

Most reported EnVeo PRO problems

EnVeo PRO models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EnVeo™ PRO ENVPRO-16-US

  Aortic valve, prosthesis, percutaneously delivered
  1 recall23 deaths197 reports
• EnVeo™ PRO ENVPRO-14-US

  Aortic valve, prosthesis, percutaneously delivered
  1 recall4 deaths55 reports

Recent EnVeo PRO adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2025Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, WHILE PREPPING THE DELIVERY CATHETER SYSTEM (DCS) TO LOAD THE VALVE, THE BLUE DEPLOYMENT HANDLE PULLED APART ON THE END NEAR THE WHITE DIRECTIONAL ARROWS. THE DCS WAS EXCHANGED FOR A NEW ONE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22537202 ↗
• MalfunctionJul 17, 2025Peeled/Delaminated; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Peeled/Delaminated; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AS THE KNOB OF THE DELIVERY CATHETER SYSTEM WAS BEING TURNED TO OPEN THE CAPSULE AND EXPOSE THE PADDLE POCKETS, THE "TURNING KNOB" FELL APART. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22533010 ↗
• MalfunctionJul 17, 2025Crack; Peeled/Delaminated; Use of Device Problem; Detachment of Device or Device Component; Difficult to Open or Close; Device Dislodged or Dislocated; Crack; Peeled/Delaminated; Use of Device Problem; Detachment of Device or Device Component; Difficult to Open or Close; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF A 34 MM TRANSCATHETER BIOPROSTHETIC VALVE, THE FIRST DEPLOYMENT WAS DEEP AND THE VALVE APPEARED TO MIGRATE VENTRICULAR THROUGHOUT THE DEPLOYMENT DESPITE NARROWED LEFT VENTRICULAR OUTFLOW TRACT AND RAPID PACING. ON THE INITIAL DEPLOYMENT, A TAB FROM THE ACTUATOR CAME LOOSE AND WAS SNAPPED BACK INTO PLACE. UPON RECAPTURE OF THE VALVE UP THE 2ND-3RD NODE, THE DEPLOYMENT KNOB BROKE AND WAS UNABLE TO BE ASSEMBLED TOGETHER. THE DEVICE WAS ABLE TO BE RECAPTURED "ENOUGH" TO SAFELY REMOVE FROM THE PATIENT. A 26 MM NON-MEDTRONIC VALVE (EDWARDS S3) VALVE WAS IMPLANTED WITH NO ISSUES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532611 ↗
• MalfunctionJul 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, WHILE LOADING THE VALVE, THE BLUE HANDLE OF THE DELIVERY CATHETER SYSTEM (DCS) BROKE APART. THE PADDLES HAD JUST BEEN COVERED AND THE TECH BEGAN ROLLING THE VALVE CLOSED. THE HANDLE WAS ABLE TO BE SNAPPED BACK TOGETHER. THE DCS WAS NOT USED AND A NEW DCS WAS USED FOR IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22518682 ↗
• MalfunctionJul 15, 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, THE VALVE WAS RECAPTURED THREE TIMES. ON THE THIRD RECAPTURE THE HANDLE OF THE DELIVERY CATHETER SYSTEM (DCS) SEPARATED. THE CAPSULE WAS CLOSED TO 2/3 BEFORE THE SEPARATION OCCURRED. THE ACTUATOR WAS ABLE TO BE SNAPPED BACK TOGETHER AND THE WAS ABLE TO RECAPTURE THE DEVICE. THE DCS AND VALVE WERE REMOVED FROM THE PATIENT AND 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 22507736 ↗
• MalfunctionJul 15, 2025Difficult or Delayed Positioning; Peeled/Delaminated; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Difficult or Delayed Positioning; Peeled/Delaminated; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE DELIVERY CATHETER SYSTEM (DCS) HANDLE BROKE DURING A PARTIAL RECAPTURE WHEN THE HANDLE WAS TWO-THIRDS CLOSED. THE HANDLE WAS SNAPPED BACK ON THE DCS AND ALTHOUGH THERE WAS REPORTED DIFFICULTY IN RECAPTURING THE VALVE, THE VALVE WAS RECAPTURED AND THE SYSTEM WAS WITHDRAWN SAFELY. THE VALVE WAS RECAPTURED DUE TO AN INADEQUATE IMPLANT DEPTH. THE VALVE WAS REPLACED TO DUE TO PARTIAL DEPLOYMENT IN THE BODY AND A SECOND VALVE WAS IMPLANTED UNEVENTFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22507075 ↗
• MalfunctionJul 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE DELIVERY CATHETER SYSTEM (DCS) WAS BEING PREPPED ON THE BACK TABLE. THE CAPSULE OF THE DCS WAS OPENED WITH THUMB TRIGGER AND THEN TURNED TO OPEN THE CAPSULE TO FULLY LOAD THE VALVE. WHILE TURNING THE DCS KNOB TO OPEN, THE DEPLOYMENT KNOB FELL APART AND WAS COMPLETELY REMOVED FROM THE DCS. THIS DCS WAS NEVER USED IN A PATIENT. A NEW DCS WAS USED TO IMPLANT THE VALVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506903 ↗
• MalfunctionJul 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE DELIVERY CATHETER SYSTEM (DCS) DEPLOYMENT KNOB BROKE DURING VALVE LOADING. THE PRODUCT WAS NEVER USED IN THE PATIENT. A NEW DCS WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506852 ↗
• MalfunctionJul 15, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, INTO A HEAVILY CALCIFIED SURGICAL VALVE HOMOGRAFT, THE VALVE WAS LOADED APPROPRIATELY AND CONFIRMED BY THE IMPLANT TEAM. THE DELIVERY CATHETER SYSTEM (DCS) TRACKED THROUGH THE AORTA SMOOTHLY UNTIL THE SINO-TUBULAR JUNCTION (STJ). THE DCS WAS PULLED BACK SLIGHTLY ALONG WITH THE WIRE AND THEN CAREFULLY ADVANCED SUCCESSFULLY CROSSING THE VALVE. FIVE ATTEMPTS WERE MADE TO DEPLOY THE VALVE IN THE APPROPRIATE POSITION. EACH TIME, THE VALVE SHIFTED INTO A LOW POSITION; THE INFLOW MOVED VENTRICULAR. THIS WAS DISCUSSED BY THE TEAM AND DETERMINED TO BE RELATED TO PATIENT ANATOMY. ON THE SIXTH ATTEMPT, FOLLOWING A FULL RECAPTURE, THE HANDLE OF THE DCS BROKE APART AROUND THE THUMB SLIDE. THE SYSTEM WAS REMOVED AND A NEW VALVE AND DCS WERE USED FOR SUCCESSFUL IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506628 ↗
• InjuryJul 15, 2025Detachment of Device or Device Component; Patient Device Interaction Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AT 60% DEPLOYMENT, THE BLUE HANDLE OF THE DELIVERY CATHETER SYSTEM (DCS) BROKE IN HALF AND THE VALVE COULD NOT BE RECAPTURED. THE PATIENT BECAME ASYSTOLIC WITH NO BLOOD PRESSURE. CARDIOPULMONARY RESUSCITATION WAS INITIATED FOR FOUR MINUTES AND EPINEPHRINE WAS ADMINISTERED. THE HANDLE OF THE DCS WAS PUT BACK TOGETHER AND THE VALVE WAS RECAPTURED. THE PATIENT RECOVERED; THE DCS AND VALVE WERE WITHDRAWN FROM THE PATIENT AND NOT USED FOR IMPLANT. SUBSEQUENTLY, A NEW DCS WAS USED TO SUCCESSFULLY IMPLANT A NEW VALVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension

  MAUDE report 22506441 ↗
• MalfunctionJul 15, 2025Difficult or Delayed Positioning; Detachment of Device or Device Component; Difficult to Open or Close; Difficult or Delayed Positioning; Detachment of Device or Device Component; Difficult to Open or Close

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE INTO A PATIENT WITH A LARGE ANNULUS AND AORTIC INSUFFICIENCY, USING A 20 FR DELIVERY CATHETER SYSTEM (DCS), AFTER THE FIRST DEPLOYMENT ATTEMPT, THE PHYSICIAN NOTICED EXCESSIVE TENSION IN THE SYSTEM WHEN RECAPTURING THE VALVE. ANOTHER ATTEMPT WAS MADE TO DEPLOY THE VALVE, HOWEVER THE PROPER DEPTH WAS NOT ATTAINED. DURING THE RECAPTURE, A "POPPING SOUND" FROM THE CATHETER HANDLE WAS HEARD, AND EXCESSIVE TENSION IN THE SYSTEM WAS OBSERVED AGAIN. THE HANDLE WAS NOT IDLE. THE VALVE WAS ABLE TO BE FULLY RECAPTURED. THE VALVE AND DCS WERE REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE HANDLE OF THE DCS WAS PARTIALLY SEPARATED. A SECOND VALVE WAS LOADED ONTO A NEW DCS AND THE VALVE WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506230 ↗
• MalfunctionJul 15, 2025Difficult or Delayed Positioning; Detachment of Device or Device Component; Difficult or Delayed Positioning; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT BEFORE THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS LOADED BY AN EXPERIENCED MEDTRONIC PERSONNEL AND CONFIRMED WITH VISUAL AND TACTILE INSPECTIONS. DURING THE IMPLANT, THE VALVE WAS RECAPTURED DUE TO IMPLANT DEPTH AND DURING THE SECOND DEPLOYMENT ATTEMPT, THE DELIVERY CATHETER SYSTEM (DCS) HANDLE BROKE APART. THE PHYSICIAN NOTED THE KNOB FELT LOOSE BUT NO RESISTANCE OR PRESSURE WAS FELT, AND THE PATIENT¿S ANATOMY WAS NOT TORTUOUS. THE VALVE WAS RECAPTURED USING THE END-CAP RETRIEVAL MECHANISM AND THE SYSTEM WAS WITHDRAWN. SUBSEQUENTLY, A SECOND VALVE WAS LOADED ONTO A NEW DCS AND IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506012 ↗
• MalfunctionJul 15, 2025Crack; Difficult or Delayed Positioning; Peeled/Delaminated; Detachment of Device or Device Component; Difficult to Advance; Difficult to Open or Close; Crack; Difficult or Delayed Positioning; Peeled/Delaminated; Detachment of Device or Device Component; Difficult to Advance; Difficult to Open or Close

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, MULTIPLE VASCULAR CHALLENGES WERE REPORTED. PATIENT HAD CALCIFIED COMMON FEMORAL ARTERIES AND THERE WERE DIFFICULTIES GETTING THE PERCLOSE'S TO TAKE. THE PHYSICIAN DECIDED TO USE THE EVOLUT-R VALVE DUE TO SMALLER VESSELS. THE MINIMUM ACCESS VESSEL DIAMETER WAS 5.6 MM. THE VALVE WAS LOADED BY A MEDTRONIC REPRESENTATIVE WITH A GOOD FLUORO CHECK. IT WAS OBSERVED AS THE PHYSICIAN ADVANCED THE DEVICE, THE PHYSICIAN DID NOT ARTICULATE, BUT IT APPEARED THE PHYSICIAN APPLIED MORE FORCE THAN NORMAL TO TRACK THE DEVICE WHEN ADVANCED ACROSS THE ANNULUS. DURING THE FIRST DEPLOYMENT, THE VALVE WAS TOO HIGH AT 80% AND WAS RECAPTURED. AS THE PHYSICIAN REACHED THE END OF THE HANDLE TRAVEL ON THE DELIVERY CATHETER SYSTEM (DCS), FLUORO SHOWED THE CAPSULE DID NOT COMPLETELY CLOSE TO THE NOSE CONE AND THE OVERDRIVE WAS REQUIRED TO CLOSE THE CAPSULE. DURING THE OVERDRIVE A LOUD NOISE WAS HEARD AND THE HANDLE OF THE DCS BROKE IN THREE SPOTS. THE CAPSULE WAS UNABLE TO CLOSE COMPLETELY BUT THE FRAME WAS NOT EXPOSED. THE DCS AND VALVE WERE REMOVED UNEVENTFULLY. A SECOND VALVE WAS LOADED ONTO A SECOND DCS AND W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505752 ↗
• MalfunctionJul 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, WHILE LOADING THE VALVE, THE HANDLE OF THE DELIVERY CATHETER SYSTEM (DCS) BROKE. THE PORTION WITH THE ARROWS ON IT WHERE THE HANDLE SNAPS IN PLACE CRACKED DOWN THE SEAM. THE DCS WAS NOT USED AND A NEW DCS WAS USED FOR IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22501299 ↗
• MalfunctionJul 14, 2025Detachment of Device or Device Component; Difficult to Open or Close; Detachment of Device or Device Component; Difficult to Open or Close

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS PREPARED AND LOADED ONTO THE DELIVERY CATHETER SYSTEM (DCS) WITHOUT INCIDENT. FLUOROSCOPIC INSPECTION WAS PERFORMED AND INDICATED A SUCCESSFUL LOAD. THE SYSTEM WAS INTRODUCED OVER A NON-MEDTRONIC GUIDEWIRE USING AN INLINE SHEATH. THE DCS WAS ADVANCED THROUGH THE PATIENT'S UNREMARKABLE ANATOMY, OVER THE AORTIC ARCH, AND THROUGH THE AORTIC VALVE. THE VALVE WAS DEPLOYED TO 80%, BUT THE VALVE FRAME WAS CONSTRAINED FROM THE OPENING DUE TO HEAVY CALCIFICATION. THE VALVE WAS ATTEMPTED TO BE RECAPTURED. DURING THIS RECAPTURE, THE ACTUATOR SEPARATED INTO TWO PIECES WITH THE VALVE 75% RECAPTURED. THE PHYSICIAN NOTED TENSION WAS FELT IN THE DCS PRIOR TO THE HANDLE SEPARATING. THE PHYSICIAN WAS ABLE TO ¿PUSH THE TWO CLEAR TABS ON THE HANDLE TOWARD THE GREY HUB¿ TO COMPLETELY RECAPTURE THE VALVE, WHICH WAS STILL IN THE AORTIC POSITION. THE VALVE AND DCS WERE COMPLETELY REMOVED FROM THE PATIENT. A 16FR NON-MEDTRONIC SHEATH REPLACED THE DCS I N THE LEFT FEMORAL ARTERY. A SECOND VALVE AND SECOND DCS WERE PREPARED, AND THE VALVE WAS SUCCESSFULLY LOADED; THE SECOND LOAD WAS VERIFIED VIA FL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22501164 ↗

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