EnVeo™ R ENVEOR-N-US (UDI 00643169640337)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169640337), received between Jan 26, 2017 and Jun 23, 2025 — classified as 3 deaths, 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, IT WAS REPORTED THE VALVE WAS SLIGHTLY OVERDRIVEN WHEN IT WAS LOADED ONTO THE DELIVERY CATHETER SYSTEM (DCS). THE VALVE WAS DEPLOYED TO 80% WHEN IT WAS NOTED THAT THE VALVE WAS TOO DEEP. THE VALVE WAS PULLED UP, HOWEVER, IT MOVED TO THE INNER CURVE OF THE AORTA MAKING IT DEEPER AT THE LEFT CUSP. THE VALVE WAS RECAPTURED. DURING THE RECAPTURE, IT WAS REPORTED THAT THE DEPLOYMENT HANDLE SEPARATED. THE HANDLE WAS SNAPPED BACK TOGETHER AND THE VALVE WAS PULLED INTO THE DESCENDING AORTA. IT WAS REPORTED THAT THE VALVE AND CAPSULE LOOKED DEFORMED WITH POSSIBLY ONE PADDLE APPEARING OUT OF POCKET. THE VALVE AND DCS WERE REMOVED FROM THE PATIENT. A NEW VALVE WAS LOADED ONTO A NEW DCS AND WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. OF NOTE, THE PATIENT HAD A PRE-EXISTING LEFT VENTRICULAR ASSIST DEVICE AND AORTIC INSUFFICIENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310423 ↗
• 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, UPON INSPECTION OF THE DELIVERY CATHETER SYSTEM (DCS), THE BACK OF THE DEPLOYMENT HANDLE WAS CRACKED. THE DCS WAS DAMAGED IN TRANSIT AND NOT USED FOR IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298979 ↗
• MalfunctionMay 7, 2018Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE DELIVERY CATHETER SYSTEM (DCS) WAS ADVANCED, CROSSED THE VALVE, AND UPON DEPLOYMENT THE CAPSULE DID NOT MOVE. IT WAS REPORTED THAT THE CAPSULE WAS BROKEN AND WOULD NOT OPEN. THE VALVE AND DCS WERE RECAPTURED AND WITHDRAWN FROM THE BODY. A NEW VALVE WAS LOADED ONTO A NEW DCS AND THE VALVE WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7492564 ↗
• MalfunctionApr 13, 2018Material Separation; Positioning Problem; Material Separation; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS RECAPTURED TWICE DUE TO IMPROPER DEPTH. UPON THE THIRD ATTEMPT AT DEPLOYMENT, THE DELIVERY CATHETER SYSTEM (DCS) WOULD NOT UNSHEATH. IT WAS REPORTED THAT IT MAY HAVE GONE PAST THE POINT OF NO RECAPTURE. THE CAPSULE WAS NOT MOVING WHEN THE HANDLE WAS MOVING. THE CAPSULE WAS FULLY CLOSED AND THE DELIVERY CATHETER SYSTEM (DCS) WAS REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE CAPSULE WAS SPLIT IN HALF WITH THE VALVE STUCK IN THE CAPSULE. THE CAPSULE WAS BROKEN NEAR THE PROXIMAL PORTION OF THE CAPSULE, HOWEVER NO PIECES REMAINED IN THE PATIENT. NO RESISTANCE WAS FELT BY THE PHYSICIAN AND IT WAS REPORTED THE PATIENT HAD A TORTUOUS AND CALCIFIED ANATOMY. A DIFFERENT VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE USED FOR A SUCCESSFUL DEPLOYMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7430886 ↗
• InjuryMar 16, 2018Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A NON-MEDTRONIC SHEATH WAS INTRODUCED TO THE PATIENT. A PRE-BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED AND THE VALVE WAS ADVANCED. THE VALVE WOULD NOT CROSS THE ANNULUS. THE VALVE WAS REMOVED AND A BAV WAS PERFORMED. THE VALVE WAS RE-ADVANCED, HOWEVER, THE VALVE WOULD NOT CROSS THE ANNULUS. THE VALVE WAS REMOVED AND A BAV WAS PERFORMED. THE VALVE WAS ADVANCED AND WOULD NOT CROSS THE ANNULUS AGAIN. AS THE VALVE WAS ATTEMPTING TO BE ADVANCED, THE PATIENT'S PRESSURE DROPPED TO 20MMHG. THE PATIENT WAS PLACED ON CARDIO PULMONARY BYPASS. THERE WAS NO ANNULUS OR ARCH DISSECTION. IT WAS REPORTED THAT THERE WAS AN ABDOMINAL AORTIC ANEURYSM (AAA) DISSECTION AND A STENT WAS PLACED. IT WAS REPORTED THE DISSECTION OCCURRED DUE TO THE NON-MEDTRONIC SHEATH AND DCS PASSING THE AAA SO MANY TIMES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Low Blood Pressure/ Hypotension; Vascular Dissection

  MAUDE report 7345208 ↗
• MalfunctionFeb 19, 2018Shelf Life Exceeded; Shelf Life Exceeded

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, TWO DELIVERY CATHETER SYSTEMS (DCS) USED FOR IMPLANT HAD EXPIRED TWO DAYS PRIOR TO THE PROCEDURE. BOTH DCS WERE FROM HOSPITAL OWNED STOCK AND THERE WERE NO OTHER DCS ON SITE. THE PHYSICIAN WAS MADE AWARE OF THE USE OF EXPIRED PRODUCT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7280146 ↗
• MalfunctionDec 14, 2017Difficult To Position; Material Separation; Difficult To Position; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A NON-MEDTRONIC INTRODUCER SHEATH WAS INSERTED. THE DELIVERY CATHETER SYSTEM (DCS) NOSECONE AND CAPSULE WERE TWISTED TO ADVANCE THROUGH THE SHEATH. ADDITIONAL TWISTING OCCURRED TO ADVANCE THE SYSTEM THROUGH THE TORTUOUS ANATOMY. UPON THE ATTEMPT AT DEPLOYMENT, A CAPSULE SEPARATION WAS NOTED AND THE DCS WAS UNABLE TO DEPLOY THE VALVE. THE DCS WAS WITHDRAWN FROM THE BODY. THE NOSE CONE AND INNER CANNULA HELD THE CAPSULE ON THE DCS AS IT WAS REMOVED. A SECOND VALVE WAS LOADED TO A SECOND DCS AND USED FOR IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7117528 ↗
• MalfunctionDec 6, 2017Positioning Failure; Material Separation; Difficult to Advance; Positioning Failure; Material Separation; Difficult to Advance

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, DUE TO A TORTUOUS DESCENDING AORTA AND ABDOMINAL AORTIC ANEURYSM GRAFT, THERE WAS DIFFICULTY ADVANCING THE DELIVERY CATHETER SYSTEM (DCS) TO THE ASCENDING AORTA. ONCE THE DCS WAS POSITIONED IN THE AORTA, VISUAL DISRUPTION OF THE PROXIMAL CAPSULE WAS NOTED. IT WAS REPORTED AN AREA OF THE CAPSULE APPEARED LESS OPAQUE UNDER FLUOROSCOPY. AN X-RAY SHOWED THE AREA OF CONCERN AS "TWISTED/STRETCHED." THE DELIVERY HANDLE WAS ROTATED TWO TURNS AND THE DCS WOULD NOT PERFORM. THE DCS WAS REMOVED FROM THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7087734 ↗
• DeathAug 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, INTO A CALCIFIED NATIVE VALVE, THE PATIENT'S PRESSURE DECREASED DURING INITIAL DEPLOYMENT AND IT COULD NOT BE RESTORED. THE VALVE WAS NOT IMPLANTED AND WAS WITHDRAWN FROM THE PATIENT. THE VALVE AND DCS WERE DISCARDED. THE PATIENT WAS TAKEN TO SURGERY FOR VALVE REPLACEMENT AND A SURGICAL VALVE (UNKNOWN MANUFACTURER) WAS IMPLANTED. IT WAS REPORTED THAT MONITORED ANESTHESIA CARE (MAC) WAS USED INSTEAD OF GENERAL ANESTHESIA AND GENERAL ANESTHESIA MAY HAVE PROVIDED BETTER CONTROL DURING THE PROCEDURE.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 6836010 ↗
• DeathJul 18, 2017Positioning Problem; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS DEPLOYED TO 80% AND RECAPTURED THREE TIMES IN AN ATTEMPT TO OBTAIN PROPER PLACEMENT. AFTER THE THIRD RECAPTURE, BLOOD PRESSURE DECREASED. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED BY HOSPITAL STAFF BUT THE PATIENT DID NOT RECOVER AND SUBSEQUENTLY EXPIRED.

  Patient problems: Death; Low Blood Pressure/ Hypotension

  MAUDE report 6721457 ↗
• InjuryJun 18, 2017Difficult to Advance; Difficult to Advance

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A 16 AND 18 FRENCH DILATOR WERE INSERTED SEQUENTIALLY IN THE RIGHT FEMORAL ACCESS SITE. THE DELIVERY CATHETER SYSTEM (DCS) WAS UNABLE TO ADVANCE AND A 20 FRENCH DILATOR WAS INSERTED. THE DCS WAS UNABLE TO ADVANCE AND THE 20 FRENCH DILATOR WAS INSERTED AGAIN WITH DIFFICULTY THROUGH THE ILIAC ARTERY. HYPOTENSION OCCURRED AND AN RIGHT EXTERNAL ILIAC ARTERY DISSECTION WAS NOTED. THE DISSECTION WAS SURGICALLY REPAIRED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 6649340 ↗
• InjuryMay 31, 2017Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS POSITIONED TOO HIGH DUE TO THE PIGTAIL CATHETER NOT BEING SEATED. THIS DELIVERY CATHETER SYSTEM (DCS) WAS PULLED OUT OF THE ANNULUS TO RECAPTURE THE VALVE BUT AT APPROXIMATELY 50% RECAPTURE, ANGIOGRAPHY SHOWED BUCKLING OF THE DCS. A SECOND ATTEMPT WAS MADE TO RECAPTURE BUT WAS UNSUCCESSFUL. THE VALVE WAS DRAGGED TO THE DESCENDING AORTA IN A THIRD ATTEMPT TO RECAPTURE WITHOUT SUCCESS. IT WAS REPORTED THAT THE VALVE WAS DEPLOYED IN THE DESCENDING AORTA DUE TO USING THE INLINE SHEATH AND NOT A 20 FRENCH SHEATH. A SECOND TRANSCATHETER BIOPROSTHETIC VALVE WAS LOADED ONTO A NEW DCS AND SUCCESSFULLY DEPLOYED WITHOUT INCIDENT ON THE FIRST ATTEMPT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6600866 ↗
• DeathMay 18, 2017Perivalvular Leak; Difficult to Advance; Device Dislodged or Dislocated; Perivalvular Leak; Difficult to Advance; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS IMPLANTED AT AN OPTIMAL DEPTH OF 3 MM ON THE NON-CORONARY CUSP (NCC) AND LEFT CORONARY CUSP (LCC). A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED MILD¿MODERATE PARAVALVULAR LEAK (PVL). IT WAS DECIDED TO PERFORM A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WITH A 28 MM NON-MEDTRONIC BALLOON. THE DISTAL MARKER OF THE BALLOON WAS PLACED APPROXIMATELY 1-2 MM BELOW THE INFLOW TRACT OF THE VALVE AND THE PATIENT WAS PACED AT 180 BEATS PER MINUTE (BPM) WHILE THE BALLOON WAS INFLATED. WHILE DEFLATING THE BALLOON, PACING WAS TURNED OFF. WHEN STARTING TO PULL THE BALLOON OUT FROM THE VALVE, IT WAS NOTED THAT THE BALLOON WAS NOT COMPLETELY DEFLATED AND THE VALVE SUBSEQUENTLY DISLODGED. AFTER THE BALLOON WAS REMOVED FROM THE VALVE AND PULLED INTO THE DESCENDING AORTA, THE VALVE WAS NOTED TO BE SITTING IN THE ASCENDING AORTA, JUST BELOW THE OSTIUM OF THE INNOMINATE ARTERY. A SECOND TRANSCATHETER BIOPROSTHETIC VALVE WAS LOADED AND INSERTED INTO THE PATIENT USING TRANSFEMORAL ACCESS ON THE LEFT SIDE. THE VALVE TRACKED WELL THROUGH THE ANATOMY BUT THEN HAD DIFFICULTY PASSING THROUGH THE

  Patient problems: Cardiac Tamponade; Death; Heart Failure; Low Blood Pressure/ Hypotension; Pericardial Effusion; Vascular Dissection

  MAUDE report 6575187 ↗
• InjuryMay 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE DELIVERY CATHETER SYSTEM (DCS) WAS INSERTED THROUGH CALCIFIED VESSELS USING THE INLINE SHEATH. THE DCS WAS UNABLE TO ADVANCE INTO THE LEFT COMMON ILIAC ARTERY. THE DCS WAS WITHDRAWN AND SERIAL DILATATION WAS PERFORMED. A 20 FRENCH SHEATH WAS INSERTED AND UNABLE TO PASS BEYOND THE ILIAC BIFURCATION. THE PATIENT BECAME HYPOTENSIVE FOLLOWING THIS ATTEMPT. PERIPHERAL ANGIOGRAPHY REVEALED A LARGE PERFORATION IN THE LEFT EXTERNAL ILIAC. AN OPEN CUTDOWN AND REPAIR WAS PERFORMED. THE PHYSICIAN REPORTED IT WAS UNCLEAR WHAT CAUSED THE INJURY. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; Low Blood Pressure/ Hypotension; Perforation

  MAUDE report 6540188 ↗
• InjuryJan 26, 2017Physical Resistance; Physical Resistance

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, STENTS WERE IMPLANTED TO REPAIR THE RIGHT FEMORAL ARTERY. IT WAS REPORTED THERE WAS SOME RESISTANCE FELT WHILE ADVANCING THE DCS, BUT IT WAS UNKNOWN WHAT CAUSED THE VASCULAR INJURY. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 6280200 ↗

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-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-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-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