EnVeo™ PRO ENVPRO-14-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00643169987203), received between May 17, 2018 and Jul 15, 2025 — classified as 4 deaths, 18 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (27 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• 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, 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, 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 DEPLOYED AT AN IMPROPER DEPTH AND RECAPTURED TWICE. WHILE RECAPTURING THE VALVE FOR THE SECOND TIME, WHEN THE CAPSULE WAS 2/3 CLOSED, THE HANDLE OF THE DELIVERY CATHETER SYSTEM (DCS) CAME APART IN PIECES. THE PHYSICIAN WAS ABLE TO SNAP THE HANDLE BACK TOGETHER PARTIALLY IN ORDER TO RECAPTURE THE VALVE. THE ENTIRE SYSTEM WAS REMOVED AND A NEW VALVE AND DCS WAS USED FOR IMPLANT. NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494280 ↗
• 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, WHEN REMOVING THE BOX FROM THE SHELF, A NOISE WAS HEARD INSIDE. THE BOX WAS OPENED AND IT WAS REPORTED THAT THE HANDLE OF THE DELIVERY CATHETER SYSTEM WAS NOT CONNECTED. IT APPEARED TO BE THE DEPLOYMENT KNOB; HOWEVER, THE PACKAGE WAS NOT OPENED TO CONFIRM WHAT PART OF THE HANDLE THAT WAS NOT CONNECTED. IT WAS NOT USED DURING A CASE. IT WAS REPORTED THERE WAS NO DAMAGE TO THE PACKING PRIOR TO OPENING IT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494004 ↗
• MalfunctionJul 11, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE WITH THIS DELIVERY CATHETER SYSTEM (DCS) AT 80% DEPLOYMENT, THE VALVE DISLODGED INTO THE ASCENDING AORTA. WHILE REPCATURING, AT ABOUT 30% DEPLOYMENT, THE ACTUATOR HANDLE SEPARATED INTO TWO PIECES. THE VALVE WAS ABLE TO BE RECAPTURED TO 20% WHICH ALLOWED IT TO BE WITHDRAWN INTO THE SHEATH AND SAFELY REMOVED. A SECOND VALVE AND DCS WERE USED FOR SUCCESSFUL IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22481102 ↗
• MalfunctionJul 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, DUE TO PATIENT ANATOMY, THE VALVE HAD TO BE INDIVIDUALLY SIZED. BASED ON SINUS OF VALSALVA (SOV) DIAMETER OF GREATER THAN 29 MM AND AN AVERAGE DIAMETER OF 23.5 MM, A 29MM VALVE WAS CHOSEN FOR IMPLANT. DURING THE LOADING OF THIS VALVE, IT WAS REPORTED BY BOTH THE LOADER AND THE MEDTRONIC REP THAT THE BLUE PLASTIC SHELL ON THE DEPLOYMENT KNOB WAS BEGINNING TO SEPARATE. THIS SEPARATION WAS MOST PROMINENT PAST THE 80% LOAD PHASE. THE VALVE WAS NEVER FULLY LOADED AND THIS DELIVERY CATHETER SYSTEM (DCS) WAS NOT USED IN THE PATIENT. DURING TWO ATTEMPTED DEPLOYMENTS, THE VALVE WAS REPORTED TO HAVE MOVED VENTRICULAR. THE PHYSICIAN DECIDED THIS VALVE WAS TO LARGE TO BE IMPLANTED. THE VALVE WAS RECAPTURED AND REMOVED FROM THE PATIENT. A 26 MM VALVE WAS SUCCESSFULLY IMPLANTED WITH A NEGLIGIBLE GRADIENT AND NO PARAVALVULAR LEAK (PVL) REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480594 ↗
• MalfunctionJul 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, UPON DEPLOYMENT OF THE VALVE THE C APSULE OF THE DELIVERY CATHETER SYSTEM (DCS) WAS AT APPROXIMATELY 1/3 OPENED WHEN THE HANDLE SEPARATED INTO TWO PIECES. THE PHYSICIAN WAS ABLE TO PUSH THE TWO PIECES BACK TOGETHER AND AN AUDIBLE CLICK WAS HEARD. THE VALVE WAS DEPLOYED ON THE FIRST ATTEMPT. THE VALVE LOADER WAS REPORTED TO BE VERY EXPERIENCED. THE KNOB TABS WERE INTACT, THE DEPLOYMENT KNOB TRIGGER WAS NOT USED AND THE HANDLE WAS NOT OVER-DRIVEN AT ANY POINT. NO UNUSUAL TENSION WAS FELT IN THE DCS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479916 ↗
• MalfunctionJul 10, 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, THE DELIVERY CATHETER SYSTEM (DCS) HANDLE BROKE DURING THE LOADING PROCESS WHILE CLOSING. THE CAPSULE WAS CLOSED ONE-THIRD WHEN THE HANDLE BROKE. THERE WAS NO UNUSUAL TENSION DURING LOADING. IT WAS UNKNOWN IF THE TABS WERE INTACT PRIOR TO USE. AS A RESULT, THE DCS WAS NOT USED FOR IMPLANT. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22475188 ↗
• MalfunctionJul 10, 2025Fracture; Peeled/Delaminated; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Device Handling Problem; Fracture; Peeled/Delaminated; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Device Handling Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE ACTUATOR ON THE DELIVERY CATHETER SYSTEM (DCS) SEPARATED DURING DEPLOYMENT. THE SEPARATION OCCURRED WHILE THE DCS CAPSULE WAS 2/3 OPEN. THE PHYSICIAN THOUGHT THAT THERE WAS SOME UNUSUAL TENSION FELT DURING DEPLOYMENT. IT IS POSSIBLE THAT ONE OF THE DEPLOYMENT KNOB TABS WAS BROKEN. THE VALVE WAS STILL ABLE TO BE DEPLOYED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22475070 ↗
• MalfunctionJul 10, 2025Fracture; Peeled/Delaminated; Detachment of Device or Device Component; Device Dislodged or Dislocated; Fracture; Peeled/Delaminated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, DURING THE ATTEMPT TO DEPLOY THE V ALVE, THE VALVE ¿DID NOT STICK¿ IN THE NATIVE ANNULUS AND WOULD DISLODGE. THE VALVE WAS RECAPTURED AND WITHDRAWN FROM THE PATIENT. A SECOND VALVE WAS LOADED ONTO A SECOND DELIVERY CATHETER SYSTEM (DCS) AND INSERTED IN THE PATIENT. THE VALVE WAS RECAPTURED ONCE BECAUSE THE VALVE ALSO WOULD NOT STICK IN THE NATIVE ANNULUS AND DISLODGED. THE IMPLANTER COMMENTED THE HANDLE OF THE DCS DID NOT FEEL AS THOUGH IT WAS TURNING AS EXPECTED. DURING THE ATTEMPT TO DEPLOY THE VALVE, THE DEPLOYMENT ACTUATOR OF THE DCS BROKE; THE VALVE WAS PARTIALLY RECAPTURED AND SAFELY WITHDRAWN FROM THE PATIENT. SUBSEQUENTLY, A NON-MEDTRONIC VALVE WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22474356 ↗
• MalfunctionJul 10, 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) DEPLOYMENT KNOB SEPARATED COMPLETELY DURING DEPLOYMENT WHILE THE VALVE WAS OPENED TO 20%. THE DEPLOYMENT KNOB WAS PUT BACK TOGETHER ENOUGH TO RECAPTURE THE VALVE AND THE SYSTEM WAS REMOVED. THE VALVE WAS STUCK IN THE DCS DUE TO THE SEPARATION. NO ABNORMAL TENSION WAS REPORTED IN THE SYSTEM. THE VALVE AND DCS WERE NOT USED AND A NEW VALVE AND DCS WERE SUCCESSFULLY USED FOR IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467299 ↗
• MalfunctionJul 9, 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) SEPARATED. THE VALVE WAS HALFWAY LOADED AND PUSHED INTO THE NOSE CONE AND AS THE HANDLE CONTINUED TO BE TURNED IT WAS NOTED THAT THE HANDLE HAD SEPARATED. THE VALVE APPEARED SYMMETRICAL IN THE CONE. THE VALVE WAS SUCCESSFULLY LOADED INTO A NEW DCS. THE LOADER WAS FROM THE SITE AND WAS AN EXPERIENCED LOADER WHO FELT THAT AFTER PUSHING THE INFLOW INTO THE CONE AS HE STARTED TURNING THE KNOB "SOMETHING DIDN'T FEEL RIGHT". NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461723 ↗
• MalfunctionJul 9, 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 DEPLOYMENT KNOB HANDLE OF THE DELIVERY CATHETER SYSTEM (DCS) BROKE WHILE UNWINDING TO OPEN THE CAPSULE TO LOAD THE VALVE. A SECOND DCS WAS USED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459863 ↗
• MalfunctionJul 8, 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 PARTIAL DEPLOYMENT OF THIS 29 MILLIMETER (MM) TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE DISLODGED VENTRICULAR. THE VALVE WAS RECAPTURED AND REPOSITIONED TWICE. ON THE THIRD ATTEMPT TO DEPLOY, THE VALVE WAS TOO DEEP. THE VALVE WAS ATTEMPTED TO BE RECAPTURED HOWEVER THE ACTUATOR SEPARATED INTO FOUR PIECES. THE CAPSULE WAS CLOSED ONE-THIRD PRIOR TO ACTUATOR SEPARATION. THE VALVE WAS RECAPTURED BY MANUALLY MANIPULATING THE DELIVERY CATHETER SYSTEM (DCS). IT WAS NOTED THAT BOTH DEPLOYMENT KNOB TABS BROKE OFF DURING THE THIRD RECAPTURE. THE VALVE AND DCS WERE REMOVED WITHOUT INJURY. A 26 MM VALVE WAS IMPLANTED SUCCESSFULLY. NO UNUSUAL TENSION WAS EXPERIENCED DURING RECAPTURE. IT WAS REPORTED THAT THE DCS WAS NOT OVER-DRIVEN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22443303 ↗
• MalfunctionJul 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, DURING VALVE DEPLOYMENT, THE ACTUATOR ON THE DELIVERY CATHETER SYSTEM (DCS) SEPARATED. THE VALVE WAS UNABLE TO BE FULLY DEPLOYED. THE VALVE COULD NOT BE FULLY RECAPTURED WITH THE SEPARATED ACTUATOR. THE HANDLE WAS REASSEMBLED TO THE BEST OF THE TEAM'S ABILITY, AND THE KNOB WAS ABLE TO BE TURNED AND RECAPTURED BY THE PHYSICALLY HOLDING THE HANDLE HALVES TOGETHER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440617 ↗
• MalfunctionJul 8, 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 VALVE LOADING USING THIS DELIVERY CATHETER SYSTEM (DCS), THE ACTUATOR SEPARATED. A SECOND DCS WAS OPENED AND SUCCESSFULLY PREPPED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440245 ↗
• MalfunctionJul 8, 2025Detachment of Device or Device Component; Positioning Problem; Detachment of Device or Device Component; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE (B)(6) INTO A FAILED 27 MILLIMETER (MM) MEDTRONIC SURGICAL VALVE, THE ROOT ANGLE WAS 44 DEGREES BUT THE PRIOR SURGICAL VALVE (SAV) SEEMED CANTED IN ANNULUS. THE SINUS OF VALSALVA (SOV) WAS MUCH LARGER, SO IT WAS PLANNED TO UTILIZE SNARE TO ASSIST WITH CROSSING INTO THE SAV FRAME. IT WAS REPORTED THAT THE PATIENT HAD A TORTUOUS ANATOMY. A CONFIDA GUIDEWIRE WAS USED. AN 18 FR (GORE) INTRODUCER SHEATH WAS USED. THE FIRST ATTEMPT, THE NOSECONE WAS SNARED IN DESCENDING AORTA AND ADVANCED THE DEVICE AND SNARE TOGETHER WITHOUT ISSUE. THE SAV WAS ABLE TO BE CROSSED WITH MINOR ASSISTANCE FROM THE SNARE. THE SNARE WAS THEN PULLED BACK ALONG DELIVERY CATHETER SYSTEM (DCS) (0009583098) INTO THE ARCH. THE VALVE WAS ATTEMPTED TO BE DEPLOYED WITH CONTROLLED PACING, HOWEVER THE VALVE WAS TOO DEEP AT 10 MM ON THE NON-CORONARY CUSP (NCC) AND 16 MM ON THE LEFT CORONARY CUSP (LCC). THE VALVE WAS RECAPTURED AND RE-DEPLOYED A SECOND TIME. HOWEVER, THE DCS WAS UNABLE TO COME OFF INNER CURVE. AFTER 4-5 ATTEMPTS AND UNEVEN DEPTHS, THE DCS WAS REMOVED TO EXCHANGE THE CONFIDA GUIDEWIRE WITH A DOUBLE CURVE NON-MED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440053 ↗
• MalfunctionJul 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, DURING LOADING, THE ACTUATOR OF THIS DELIVERY CATHETER SYSTEM (DCS) SEPARATED. THE EXPERIENCED LOADER REPORTED THAT THERE WAS RESISTANCE DURING LOADING. NO LOOSE TABS WERE NOTED. A NEW DELIVERY CATHETER SYSTEM (DCS) WAS USED FOR SUCCESSFUL LOADING AND IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22420735 ↗
• MalfunctionJun 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AFTER ONE RECAPTURE DUE TO THE VALVE POSITION BEING TOO HIGH, THE HANDLE FELT LOOSE. THE VALVE WAS RECAPTURED MULTIPLE TIMES AND ON THE FINAL RECAPTURE THE HANDLE OF THE DELIVERY CATHETER SYSTEM (DCS) CAME APART WHEN THE CAPSULE WAS 80% CLOSED. THE PHYSICIAN WAS ABLE TO FORCE THE HANDLE CLOSED BYPUSHING HARD ON THE CLEAR SLIDER. THE DCS WAS RECOVERED AND A NEW SYSTEM WAS USED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22362371 ↗
• MalfunctionJun 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AFTER ASSESSING THE VALVE AT 80% DEPLOYMENT, FORWARD PRESSURE WAS APPLIED TO THE DELIVERY CATHETER SYSTEM (DCS) TO DEPLOY THE VALVE, AND THE ROTATING BLUE HANDLE OF THE DCS BROKE OFF FROM THE CATHETER. DEPLOYMENT WAS COMPLETED USING THE GRAY PORTION OF THE DCS. LOADING WAS PERFORMED BY AN EXPERIENCED LOADER AND NO UNUSUAL TENSION WAS FELT DURING LOADING OR ATTEMPTED DEPLOYMENT. IT WAS REPORTED THAT NO LOOSE TABS WERE PRESENT IN THE PACKAGING AND BOTH DEPLOYMENT KNOB TABS WERE INTACT; THERE WAS NO DAMAGE NOTED ON THE DEPLOYMENT KNOB. THE DEPLOYMENT KNOB TRIGGER WAS NOT USED AND THE HANDLE WAS NOT OVER-DRIVEN AT ANY POINT IN THE PROCESS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359175 ↗
• MalfunctionJun 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 29 MM TRANSCATHETER BIOPROSTHETIC VALVE, INTO AN ANNULUS THAT MEASURED ON THE BORDERLINE FOR USING A 26 MM AND A 29 MM VALVE, ATTEMPTS WERE MADE AND WOULD NOT POSITION COAXIALLY AND WAS TOO DEEP AT 12 MM LEFT CORONARY CUSP (LCC) VS 2 MM NON-CORONARY CUSP (NCC). THE OPERATORS ATTEMPTED TWICE TO RECAPTURE AND REPOSITION. THE DECISION WAS MADE TO REPLACE THE 29 MM VALVE WITH A 26 MM VALVE. THE 29 MM VALVE WAS KEPT IN PLACE IN THE ANNULUS, FULLY FUNCTIONING AT 80% DEPLOYED WHILE A NEW 26MM VALVE WAS PREPPED. WHILE ATTEMPTING A FINAL RECAPTURE OF THE 29 MM VALVE TO REMOVE IT FOR THE SMALLER VALVE, THE ACTUATOR HANDLE ON THE DELIVERY CATHETER SYSTEM (DCS) BROKE INTO TWO PIECES. THE 29MM VALVE WAS 60% RECAPTURED, STILL FLARED AT THE DISTAL END AND PIVOTING IN THE ASCENDING AORTA WITH EACH CONSECUTIVE HEARTBEAT WHEN THIS OCCURRED, THUS PLACING THE PATIENT AT AN UNDULY HIGH RISK OF AORTIC DISSECTION. THE PHYSICIAN HAD DIFFICULTY IN MANUALLY REATTACHING THE TWO PARTS OF THE ACTUATOR IN ORDER TO FULLY RECAPTURE THE 29 MM VALVE BUT DID SO SUCCESSFULLY. THE 26 MM VALVE WAS SUBSEQUENTLY IMPLANTED SUCCESSFULLY AND THE PATIENT WAS STAB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350089 ↗
• MalfunctionJun 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 26MM TRANSCATHETER BIOPROSTHETIC VALVE, THE DEPLOYMENT KNOB OF THE DELIVERY CATHETER SYSTEM (DCS) ¿CRUMBLED¿ AND CAME APART DUE TO A VALVE MISLOAD. A BENT STRUT WAS REPORTED. THE MISLOAD WAS IDENTIFIED BY TACTILE METHOD. THE VALVE WAS LOADED ONTO A DIFFERENT DCS AND SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22349534 ↗
• MalfunctionJan 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AT 80% DEPLOYMENT AFTER MAKING ANNULAR CONTACT AND BEFORE GETTING THROUGH THE ¿RUMBLE STRIPS,¿ THE VALVE DISLODGED ABOVE THE ANNULUS AND INTO THE ASCENDINGAORTA BY THE CARDIAC OUTPUT. IT WAS REPORTED THAT THE OPERATOR DID NOT HAVE CONTROL OF THE NON-MEDTRONIC WIRE AND THE WIRE ALSO DISLODGED UP INTO THE ASCENDING AORTA. THE SYSTEM WAS REMOVED AND THE WIRE WAS ADVANCED TO SUCCESSFULLY RE-CROSS THE VALVE. AN 18 FR NON-MEDTRONIC SHEATH WAS USED IN THE RIGHT COMMON FEMORAL ARTERY THROUGHOUT THE PROCEDURE. A NEW VALVE WAS LOADED AS THE FIRST VALVE HAD BEEN IN THE BODY AND PARTIALLY DEPLOYED. THE VALVE WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21263927 ↗
• InjuryFeb 9, 2022Difficult or Delayed Positioning; Material Separation; Malposition of Device; Difficult or Delayed Positioning; Material Separation; Malposition of Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, INTO AN EXISTING 21MM NON-MEDTRONIC SURGICAL VALVE FAILING WITH AORTIC STENOSIS AND AORTIC INSUFFICIENCY, THE VALVE WAS LOADED BY AN EXPERIENCED HOSPITAL STAFF MEMBER. THE LOAD WAS CONFIRMED VIA FLUOROSCOPIC INSPECTION. THE DELIVERY CATHETER SYSTEM (DCS) WAS INSERTED INTO THE PATIENT AND ADVANCED INTO POSITION IN THE ANNULUS. UPON INITIAL DEPLOYMENT, THE VALVE FRAME APPEARED TO BE POSITIONED AT A SHALLOW DEPTH. THE VALVE WAS RECAPTURED. DURING RECAPTURE, THE CAPSULE OF THE DCS WAS NOTED TO BE POSITIONED AT A 90-DEGREE ANGLE IN RELATION TO THE PARTIALLY DEPLOYED VALVE. AT THIS POINT, THE VALVE WAS ¿NEARLY¿ FULLY RECAPTURED AND A SEVERE KINK WAS OBSERVED IN THE CAPSULE OF THE DCS, JUST ABOVE THE PADDLE POCKETS IN THE DISTAL PORTION OF THE CAPSULE. A DECISION WAS MADE TO PULL BACK THE DCS AND VALVE, ALTHOUGH NOT FULLY RECAPTURED, DOWN INTO THE DESCENDING THORACIC AORTA. THE PATIENT WAS INTUBATED DUE TO DECREASING OXYGEN SATURATION LEVELS. WITH THE DCS IN A POSITION WITH STRAIGHTER ANATOMY IN THE DESCENDING AORTA, RECAPTURE WAS ATTEMPTED; HOWEVER, THE KINK IN THE DCS REAPPEARED.

  Patient problems: Hypoxia

  MAUDE report 13501095 ↗
• InjuryOct 20, 2020Gradient Increase; Malposition of Device; Gradient Increase; Malposition of Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE INTO A PREVIOUS MEDTRONIC SURGICAL HEART VALVE, THE VALVE WAS IMPLANTED TOO SHALLOW. A DECISION WAS MADE TO IMPLANT A SECOND VALVE RESOLVING THE SHALLOW IMPLANT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10708367 ↗

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-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
• 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, Labele
• 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
• 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