EnVeo™ PRO ENVPRO-16-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 197 adverse event reports that list this exact device (DI 00643169987210), received between Apr 24, 2018 and Jul 17, 2025 — classified as 23 deaths, 94 injuries, 80 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (66 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 197 reports, 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; 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 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 ↗
• MalfunctionJul 14, 2025Peeled/Delaminated; Malposition of Device; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Peeled/Delaminated; Malposition of Device; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation

  MEDTRONIC RECEIVED INFORMATION PRIOR TO THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, THE FIRST VALVE WAS LOADED INTO THE FIRST DELIVERY CATHETER SYSTEM (DCS) THREE SEPARATE TIMES, TWO ATTEMPTS BY THE HOSPITAL STAFF AND ONE ATTEMPT BY A MEDTRONIC REPRESENTATIVE. AFTER EACH LOAD, A MISLOAD WAS IDENTIFIED BY BOTH VISUAL AND FLUOROSCOPIC INSPECTION. AFTER THE THIRD ATTEMPTED LOAD, THE PHYSICIAN REQUESTED A NEW VALVE. A SECOND VALVE WAS LOADED ONTO A SECOND DCS AND ADVANCED THROUGH THE PATIENT'S ANATOMY WITHOUT ISSUE. DURING THE ATTEMPTED DEPLOYMENT, WHILE STILL LOADED ON THE DCS, THE VALVE DISLODGED AORTIC DUE TO TORQUE BUILD UP WITHIN THE DCS. WHILE RECAPTURING THE VALVE AFTER IT DISLODGED IN THE AORTIC ARCH, THE BLUE ACTUATOR HANDLE OF THE DCS SEPARATED INTO FOUR PIECES. THE HANDLE WAS UNABLE TO BE REASSEMBLED. AFTER DISCUSSION, THE PHYSICIAN PULLED THE DCS BACK TO THE AREA JUST ABOVE THE ILIAC BIFURCATION AND WAS FORCED TO DEPLOY THE VALVE. NO FURTHER INTERVENTIONS WERE PERFORMED. THE VALVE REMAINS IN THE AREA ABOVE THE BIFURCATION. DURING DEPLOYMENT OF THIS VALVE INTO THE AREA, A THIRD VALVE AND A THIRD DCS WERE OPENED, BUT NOT LOADED. THE PHYSICIAN ABORTED THE CASE WITHOUT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22497718 ↗
• 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 ATTEMPTED TO BE RECAPTURED AFTER BEING DEPLOYED TO APPROXIMATELY 20-30%. THE REASON FOR RECAPTURE WAS THAT THE DEPTH WAS INITIALLY DEEPER THAN THE PHYSICIAN WOULD HAVE WANTED. DURING THIS INITIAL RECAPTURE ATTEMPT, THE PHYSICIAN REPORTED THAT THE DEPLOYMENT KNOB OF THE DELIVERY CATHETER SYSTEM (DCS) SPLIT IN HALF. THE GREY SLIDER TRIGGER BROKE WHEN THE KNOB SPLIT. THE PHYSICIAN WAS UNABLE TO FULLY RECAPTURE THE VALVE. THE MEDTRONIC FIELD REP WAS ABLE TO MANUALLY MANEUVER THE DCS TO FULLY RECAPTURE THE VALVE SO THAT THE VALVE AND FAILED DCS COULD BE REMOVED FROM THE BODY. ANATOMICAL TORTUOSITY WAS REPORTED. A SECOND VALVE WAS OPENED AND LOADED ONTO A NEW DCS. THE SECOND VALVE WAS IMPLANTED SUCCESSFULLY. IT WAS REPORTED THAT THE PHYSICIAN IS A HIGHLY EXPERIENCED IMPLANTER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493813 ↗
• 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 PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, WHILE INSERTING A NON-MEDTRONIC GUIDEWIRE TO CROSS THE VALVE, PRIOR TO THE DELIVERY CATHETER SYSTEM (DCS) ENTERING THE BODY, ATRIO-VENTRICULAR BLOCK (AVB) OCCURRED. THE VALVE WAS ATTEMPTED TO BE DEPLOYED, BUT DURING THE FIRST RECAPTURE AT 75%, BOTH SIDES OF THE DEPLOYMENT KNOB BROKE OFF. THE PHYSICIAN WAS ABLE TO RECAPTURE AND REMOVE THE VALVE SUCCESSFULLY. A SECOND VALVE WAS LOADED WITH A NEW DELIVERY CATHETER SYSTEM AND IMPLANTED. FOLLOWING THE VALVE PROCEDURE, A PERMANENT PACEMAKER WAS IMPLANTED FOR THE AVB BLOCK. IT WAS REPORTED THAT PER THE PHYSICIAN, THE AVB AND SUBSEQUENT NEED FOR A PACEMAKER WERE NOT CAUSED BY A MEDTRONIC DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493371 ↗
• MalfunctionJul 10, 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 LOADED AND INSPECTED BY AN EXPERIENCED LOADER. DURING THE FIRST DEPLOYMENT THE BLUE HANDLE SEPARATED. THE HANDLE WAS PRESSED TOGETHER SEVERAL TIMES WHILE ATTEMPTING TO DEPLOY THE VALVE. THE VALVE WAS IMPLANTED UPON THE THIRD DEPLOYMENT. THE DELIVERY CATHETER SYSTEM (DCS) WAS WITHDRAWN FROM THE PATIENT WITH NO COMPLICATIONS. THE MULTIPLE DEPLOYMENT ATTEMPTS WERE DUE TO SUB OPTIMAL POSITIONING OF THE VALVE. THE DEPLOYMENT KNOB TRIGGER WAS NEVER USED AND THE HANDLE WAS NOT OVER DRIVEN AT ANY POINT DURING THE PROCEDURE. THERE WAS NO UNUSUAL TENSION NOTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467491 ↗
• 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, WHILE LOADING AT ABOUT HALFWAY C OVERING THE VALVE THE HANDLE OF THE DELIVERY CATHETER SYSTEM (DCS) CAME APART. THE VALVE WAS LOADED BY THERAPY DEVELOPMENT SPECIALISTS WITH MORE THAN FOUR YEARS EXPERIENCE. IT WAS REPORTED THAT THE DEPLOYMENT KNOB TRIGGER WAS USED INITIALLY TO OPEN THE CAPSULE AND TURNED THE LAST FEW TURNS TO OPEN THE CAPSULE ALL THE WAY. THE TABS OF THE HANDLE APPEARED TO BE INTACT. THE VALVE WAS UNLOADED FROM THE DCS, LOADED INTO A SECOND DCS AND IMPLANTED UNEVENTFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467309 ↗
• MalfunctionJul 8, 2025Difficult or Delayed Positioning; Detachment of Device or Device Component; Activation Failure; Difficult or Delayed Positioning; Detachment of Device or Device Component; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE HANDLE ON THE DELIVERY CATHETER SYSTEM (DCS) SEPARATED DURING THE THIRD ATTEMPT TO RECAPTURE THE VALVE. AT THAT POINT IT WAS NOT POSSIBLE TO DEPLOY THE VALVE. THE CAPSULE WAS JUST OVER THE PROSTHESIS ABOUT 5 MM FROM PRIOR TO TOTAL RECAPTURE. AFTER THE HANDLE SEPARATED A BROKEN TAB WAS PRESENT THAT WAS NOT PRESENT IN THE PACKAGING. THE DEPLOYMENT TRIGGER WAS NOT USED AT ANY POINT IN THE PROCESS. THERE WAS NO UNUSUAL TENSION IN THE SYSTEM AND THE HANDLE WAS NOT OVER-DRIVEN. THE VALVE LOADER WAS EXPERIENCED. FOLLOWING THE HANDLE SEPARATION, THE DCS WAS CAREFULLY REMOVED FROM THE PATIENT'S BODY AND A SECOND VALVE AND DCS WAS USED TO SUCCESSFULLY IMPLANT THE VALVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22442280 ↗
• MalfunctionJul 8, 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 34MM TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS RECAPTURED IN AN ATTEMPT TO ACHIEVE A HIGHER IMPLANT POSITION. DURING THE SECOND RECAPTURE OF THE VALVE AT 2/3, THE DELIVERY CATHETER SYSTEM (DCS) (PLI-10) ACTUATOR SEPARATED. THE VALVE WAS FULLY RECAPTURED AND ALONG WITH THE DCS, BOTH WERE WITHDRAWN FROM THE PATIENT. A SECOND DCS (B)(6) WAS USED; HOWEVER, THE VALVE WAS NOT IMPLANTED. THE SECOND DCS AND VALVE WERE WITHDRAWN FROM THE PATIENT AND NOT USED FOR IMPLANT. IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE VALVE; THE PROCEDURE WAS ABORTED BECAUSE THE VALVE WOULD NOT SIT PROPERLY IN THE ANNULUS. IT WAS REPORTED THAT BOTH DEPLOYMENT KNOB TABS WERE INTACT; LOADING WAS PERFORMED BY EXPERIENCED HOSPITAL PERSONNEL AND NO TENSION WAS FELT IN THE SYSTEM DURING LOADING, DEPLOYMENT, OR RECAPTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440785 ↗
• MalfunctionJul 8, 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 WAS BEING LOADED INTO THE DELIVERY CATHETER SYSTEM (DCS), AS THE CAPSULE WAS BEING ADVANCED OVER THE VALVE, THE DELIVERY KNOB SEPARATED. THE DEPLOYMENT KNOB TRIGGER WAS NOT USED. THERE WAS NO UNUSUAL TENSION ON THE SYSTEM AND THE VALVE WAS NOT OVERDRIVEN. THE VALVE LOADER WAS NEW BUT THERE WAS NOTHING UNUSUAL ABOUT THE VALVE LOAD. FOLLOWING THE DELIVERY KNOB SEPARATION, THE DCS WAS DISCARDED AND THE VALVE WAS LOADED INTO A NEW DCS AND SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440300 ↗
• MalfunctionJul 8, 2025Detachment of Device or Device Component; Difficult to Open or Close; Positioning Problem; Detachment of Device or Device Component; Difficult to Open or Close; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS LOADED BY AN EXPERIENCED LOADER AND CONFIRMED NO MISLOAD. DURING THE INITIAL DEPLOYMENT OF THE VALVE, THE DEPTH WAS HIGH AND THE VALVE WAS RECAPTURED. THE VALVE WAS ABOUT TWO THIRDS RECAPTURED WHEN AN AUDIBLE SOUND WAS HEARD FROM THE HANDLE AND THE ACTUATOR SNAPPED APART AND SEPARATED. THE ACTUATOR WAS UNABLE TO BE REASSEMBLED AND IT WAS DECIDED TO PULL THE DELIVERY CATHETER SYSTEM (DCS) AND THE VALVE OUT OF THE BODY. THE VALVE WAS UNLOADED AND REMOVED UNEVENTFULLY FROM THE FIRST DCS ON THE TABLE. THE VALVE WAS LOADED INTO A SECOND DCS AND IMPLANTED UNEVENTFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22439370 ↗
• MalfunctionJul 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, AT 1/3 DEPLOYMENT THE SEAM ALONG THE BLUE HANDLE OF THE DELIVERY CATHETER SYSTEM (DCS) SPLIT APART. THE PHYSICIAN WAS ABLE TO SNAP THE TWO PIECES BACK TOGETHER AND THE VALVE WAS FULLY RECAPTURED AND WITHDRAWN FROM THE PATIENT. SUBSEQUENTLY, A SECOND VALVE WAS LOADED ONTO A NEW DCS AND SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22420422 ↗
• MalfunctionJul 7, 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 BLUE DEPLOYMENT HANDLE FELL APART. IT WAS REPORTED THAT THE LOADING PROCESS WAS NORMAL AND THAT THERE WAS NO ABNORMAL FORCE APPLIED TO THE CATHETER. A NEW DELIVERY CATHETER SYSTEM (DCS) WAS USED FOR IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22419928 ↗
• MalfunctionJul 7, 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 UNPACKAGED AND PREPPED IN THE USUAL FASHION. IT WAS REPORTED THAT THE HANDLE OF THE DCS FELT A LITTLE WOBBLY WHEN OPENING THE CAPSULE, BUT IT WAS INTACT. A 29MM VALVE WAS PREPPED AND LOADED INTO THE COMPRESSION LOADING SYSTEM (CLS) WITHOUT INCIDENT. THE VALVE WAS LOADED ONTO THE DCS AND THE CAPSULE ADVANCED OVER THE VALVE PADDLES AND OUTFLOW CROWNS EASILY. HOWEVER, ONCE THE CAPSULE REACHED THE COMMISSURES AND TISSUE PORTION OF THE VALVE, RESISTANCE WAS FELT AND THE HANDLE SPLIT IN HALF ALONG THE SEAMS. THE VALVE WAS UNLOADED FROM THE DCS AND NOT USED FOR IMPLANT. A NEW DCS WAS PREPPED AND THE VALVE LOADED WITHOUT INCIDENT. LOADING WAS PERFORMED BY AN EXPERIENCED LOADER. IT WAS NOTED THAT BOTH DEPLOYMENT KNOBS WERE BENT, BUT BOTH WERE ATTACHED. IT WAS ALSO NOTED THAT THE DEPLOYMENT KNOB TRIGGER WAS USED TO MOVE THE HANDLE BACK TO OPEN THE CAPSULE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412364 ↗

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