EnVeo™ R ENVEOR-US (UDI 00643169633353)Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00643169633353), received between Dec 7, 2016 and Jul 1, 2025 — classified as 5 deaths, 17 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (35 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 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• 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, 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 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, 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 ↗
• 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 26 MM TRANSCATHETER BIOPROSTHETIC VALVE, WHEN THE DELIVERY CATHETER SYSTEM (DCS) WAS OPENED AND PASSED TO MEDTRONIC PERSONNEL ON THE TABLE, IT WAS NOTED THAT THE BLUE DEPLOYMENT HANDLE WAS SPLIT INTO TWO PIECES. IT WAS REPORTED THAT THE DCS HAD A BROKEN HANDLE IN THE PACKAGE AS THERE HAD BEEN NO ATTEMPT TO USE THE DEVICE. A SECOND DCS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22339008 ↗
• MalfunctionJun 25, 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 INTO THE CAPSULE, THE DEPLOYMENT KNOB CAME APART. THE DELIVERY CATHETER SYSTEM (DCS) WAS NOT USED AND WILL BE RETURNED TO MEDTRONIC FOR ANALYSIS. A DIFFERENT DCS WAS USED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331037 ↗
• MalfunctionJun 25, 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 DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS IMPLANTED DEEP. THE VALVE WAS RECAPTURED ONCE AND THE DEPLOYMENT KNOB SEPARATED DURING RECAPTURE. THERE WAS NO SYSTEMIC BLOOD PRESSURE AT THIS TIME, SOTHE VALVE WAS DEPLOYED IN GOOD POSITION USING THE THUMB SLIDE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330811 ↗
• MalfunctionJun 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT WHILE LOADING A 29MM VALVE, THE HANDLE OF THE DELIVERY CATHETER SYSTEM (DCS) SEPARATED WHEN SPUN TO DEPLOY THE VALVE. ANOTHER DCS WAS USED FOR THE IMPLANT. THERE WAS NO PATIENT INVOLVEMENT. NOTE: THE LOADER HAD PREVIOUSLY LOADED 10 VALVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329729 ↗
• MalfunctionJun 25, 2025Difficult or Delayed Positioning; Device Difficult to Setup or Prepare; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Difficult to Open or Close; Difficult or Delayed Positioning; Device Difficult to Setup or Prepare; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Difficult to Open or Close

  MEDTRONIC RECEIVED INFORMATION THAT DURING LOADING OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, FLUOROSCOPY REVEALED A BENT STRUT. THE VALVE WAS RELOADED AND VERIFIED USING FLUOROSCOPY. THE VALVE POSITION WAS UNSATISFACTORY AND THE VALVE WAS RECAPTURED. UPON RECAPTURE, THE BLUE DEPLOYMENT HANDLE SEPARATED. THE PHYSICIAN SNAPPED THE HANDLE ONTO THE DELIVERY CATHETER SYSTEM (DCS). THE VALVE WAS RECAPTURED AND THE DCS WAS WITHDRAWN FROM THE BODY. UPON INSPECTION, THE CAPSULE WAS BENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329455 ↗
• MalfunctionJun 25, 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 THE VALVE LOADER WAS PULLING THE TRIGGER BUTTON BACK TO PULL THE DEPLOYMENT HANDLE APART TO EXPOSE THE HANDLES, THE DELIVERY CATHETER SYSTEM (DCS) BLUE HANDLE FELL APART. THE PLASTIC CASING AROUND THE TRIGGER BUTTON BROKE APART. THE VALVE WAS UNABLE TO BE LOADED. THE DCS WAS NOT USED. THE VALVE WAS LOADED ONTO A NEW DCS AND WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329249 ↗
• MalfunctionJun 24, 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 29MM VALVE INTO THE APPROPRIATE SIZE COMPRESSION LOADING SYSTEM (CLS), THE BLUE DEPLOYMENT KNOB OF THE DELIVERY CATHETER SYSTEM (DCS) SEPARATED DUE TO WHAT APPEARED TO BE EXCESSIVE FORCE. IT WAS REPORTED THAT THE SEPARATION OCCURRED WHILE THE DEPLOYMENT KNOB WAS BEING TURNED AND THAT NO UNUSUAL RESISTANCE WAS FELT WHILE LOADING. THE DEPLOYMENT KNOB WAS ASSEMBLED BACK TOGETHER TO ALLOW THE TECH TO REMOVE THE VALVE FROM THE CAPSULE. THE VALVE WAS REMOVED FROM THE CAPSULE AND WAS PLACED IN WARM STERILE WATER. THE VALVE WAS RELOADED INTO A NEW DELIVERY CATHETER AND WAS SUCCESSFULLY DEPLOYED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323176 ↗
• MalfunctionJun 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE (B747385), AFTER THE VALVE WAS RECA PTURED TWICE DUE TO DEEP POSITIONING, THE DEPLOYMENT KNOB OF THE DELIVERY CATHETER SYSTEM (DCS) SEPARATED. HYPOTENSION WAS NOTED AND THE HANDLE PIECES WERE QUICKLY REATTACHED, AND THE VALVE WAS RECAPTURED. THE SYSTEM WAS REMOVED FROM THE PATIENT. THE VALVE BECAME CONTAMINATED AFTER REMOVAL. A NEW VALVE AND DCS WERE USED FOR A SUCCESSFUL IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 22322785 ↗
• MalfunctionJun 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS 29 MM TRANSCATHETER BIOPROSTHETIC VALVE, WHILE LOADING THE VALVE ONTO THE DELIVERY CATHETER SYSTEM (DCS), THE DEPLOYMENT KNOB SPLIT IN HALF. IT WAS REPORTED THAT IT ¿POPPED¿ WHEN BEGINNING TO TURN THE KNOB. THE DCS WAS DISCARDED. THE VALVE WAS LOADED ONTO A NEW DCS AND SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309982 ↗
• MalfunctionJun 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS 29 MM TRANSCATHETER BIOPROSTHETIC VALVE, WHILE LOADING THE VALVE, THE DELIVERY CATHETER SYSTEM (DCS) WAS OVER-DRIVEN. WHEN MOVING THE DCS, THE BLUE DEPLOYMENT HANDLE CRACKED/SEPARATED. THE DCS WAS NOT USED AND THE VALVE WAS SUCCESSFULLY LOADED ONTO A NEW DCS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. OF NOTE, THE LOADER WAS HOLDING THE BACK OF THE ACTUATOR WHILE TURNING THE DEPLOYMENT HANDLE, AS OPPOSED TO HOLDING THE GRAY GRIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309875 ↗
• MalfunctionJun 23, 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 FOR BETTER POSITIONING WHEN THE BLUE HOUSING AROUND THE HANDLE (DEPLOYMENT KNOB) OF THIS DELIVERY CATHETER SYSTEM (DCS) SEPARATED ALONG THE SEAM. IT COULD NOT BE PUT BACK TOGETHER SO THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT AND SAME VALVE WAS SUCCESSFULLY IMPLANTED USING A DIFFERENT DCS OF THE SAME LOT NUMBER. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THERE WAS NO MISLOAD AND NO ANATOMY ISSUES THAT WOULD HAVE AFFECTED THE SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309700 ↗
• MalfunctionJun 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE LOADING PROCESS (95% COMPLETE) PRIOR TO IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A CRACK IN THE DEPLOYMENT KNOB OCCURRED AT THE SEAM. IT WAS SNAPPED BACK TOGETHER, THE KNOB WAS ROTATED IN BOTH DIRECTIONS AND NO FURTHER ISSUES WERE OBSERVED. THE VALVE WAS LOADED, INSPECTED VISUAL, TACTILE AND FLUOROSCOPY BEFORE IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309120 ↗
• MalfunctionJun 20, 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 LOADING, PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AFTER VIGOROUS FLUSHING OF THE ACCUTRAK PORT ON THE DELIVERY CATHETER SYSTEM (DCS), THERE WAS "JUMPING" NOTED AS THE CAPSULE WAS ADVANCED TO LOAD THE VALVE. THE PORT WAS FLUSHED, THE CAPSULE WAS OPENED AND CLOSED AND THE "JUMPING" CONTINUED. AS IT DOES NOT IMPACT DEPLOYMENT, THE TEAM PROCEEDED WITH THE LOAD. THERE WAS A MISLOAD AND WHEN ATTEMPTING TO REOPEN THE CAPSULE TO REMOVE THE VALVE, THE END CAP SEPARATED. THE END CAP WAS REALIGNED AND AN ATTEMPT WAS MADE TO UNSHEATH THE VALVE WHEN THE HANDLE (THE ACTUATOR INSIDE) BROKE INSIDE AND THE VALVE WAS UNABLE TO BE REMOVED. THE DEPLOYMENT KNOB WAS BEING TURNED IN THE DEPLOYMENT DIRECTION. ANOTHER VALVE AND DCS WERE USED TO SUCCESSFULLY IMPLANT THE VALVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NOTE: THE VALVE WAS LOADED BY A VERY EXPERIENCED TECHNICIAN. THE MISLOAD WAS IDENTIFIED VISUALLY BY THE REPRESENTATIVE WHO WAS UNABLE TO TELL WHAT THE ISSUE WAS AS THE CAPSULE WOULDN¿T FULLY OPEN. IT WAS CHALLENGING TO TELL IF THERE WAS ANY UNUSUAL RESISTANCE FELT DURING LOADING THE VALVE WITH THE ¿JUMPING" IN THE DCS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302552 ↗
• MalfunctionJun 20, 2025Difficult or Delayed Positioning; Detachment of Device or Device Component; Activation Failure; Intravalvular regurgitation; Difficult or Delayed Positioning; Detachment of Device or Device Component; Activation Failure; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE INTO A FAILED SURGICAL VALVE TRANSFEMORALLY, THE VALVE WAS IMPLANTED DEEP AND WAS RECAPTURED. REPOSITIONING WAS ATTEMPTED AND THE VALVE WAS RECAPTURED AGAIN. UPON RECAPTURE THE DELIVERY CATHETER SYSTEM (DCS) DEPLOYMENT KNOB SEPARATED. THE DEVICE WAS WITHDRAWN FROM THE BODY AND WILL BE RETURNED FOR ANALYSIS. THE PATIENT HAD OPEN AORTIC INSUFFICIENCY DURING RETRIEVAL OF THE DCS AND WHILE WAITING FOR A SECOND VALVE TO BE LOADED TO A SECOND DCS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22302078 ↗
• MalfunctionJun 20, 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 SUCCESSFUL VALVE LOAD WAS VE RIFIED BY FLUOROSCOPY. THE DELIVERY CATHETER SYSTEM (DCS) WAS INSERTED AND CROSSED THE ANNULUS. THE VALVE WAS POSITIONED HIGH AND WAS RECAPTURED ONCE. UPON 80% DEPLOYMENT, THE DEPLOYMENT KNOB SEPARATED. THE PIECES WERE HELD TOGETHER AND THE VALVE WAS DEPLOYED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298422 ↗
• MalfunctionJun 20, 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 DEP LOYMENT HANDLE SEPARATED. THE VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE NOT USED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298335 ↗
• MalfunctionJun 19, 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 LOADING OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE DEPLOYMENT KNOB OF THE DELIVERY CATHETER SYSTEM FELT "TOO EASY" TO TURN. AS THE VALVE WAS DEPLOYED ON THE BACK TABLE, THE HANDLE SEPARATED. THE SAME VALVE WAS LOADED ONTO A DIFFERENT DCS WAS USED FOR A SUCCESSFUL IMPLANT. NO IMAGES ARE AVAILABLE FOR REVIEW. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293104 ↗
• MalfunctionJun 19, 2025Difficult or Delayed Positioning; Detachment of Device or Device Component; Difficult to Open or Close; Activation Failure; Difficult or Delayed Positioning; Detachment of Device or Device Component; Difficult to Open or Close; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, VIA THE TRANSFEMORAL ARTERY, THE V ALVE WAS POSITIONED HIGH WITH MODERATE PARAVALVULAR LEAK (PVL). THE VALVE WAS RECAPTURED WITH DIFFICULTY DUE TO NOT BEING ABLE TO FULLY RECAPTURE. WHILE TRYING TO DEPLOY THE VALVE AGAIN, THE HANDLE OF THE DELIVERY CATHETER SYSTEM (DCS) SEPARATED INTO TWO PIECES AND THE VALVE COULD NOT BE DEPLOYED. THE DCS AND VALVE WERE REMOVED FROM THE PATIENT AND WILL BE RETURNED TO MEDTRONIC FOR ANALYSIS. A NEW 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 22292711 ↗
• MalfunctionJun 19, 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, DURING LOADING, THE LARGE BLUE HANDLE/TWIST KNOB OF THE DELIVERY CATHETER SYSTEM (DCS) BEGAN TO SEPARATE AT THE SEAM. THE DCS WAS NOT USED FOR IMPLANT. THE VALVE WAS LOADED ONTO A NEW DCS AND SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22290563 ↗

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-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-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-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