Trifecta™ TF-27ARecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05414734052054), received between Jul 15, 2018 and Jun 12, 2026 — classified as 18 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (11 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 27MM TRIFECTA VALVE WAS IMPLANTED ON (B)(6) 2015. IT WAS REPORTED THAT THE VALVE WAS EXPLANTED ON (B)(6) 2024. THE CAUSE OF THE EXPLANT IS UNKNOWN. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION HAS BECOME AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25491792 ↗
• InjuryOct 11, 2024Calcified; Incomplete Coaptation; Device Stenosis; Calcified; Incomplete Coaptation; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2019, A 27MM TRIFECTA VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. THE PATIENT HAD A HISTORY OF A BICUSPID AORTIC VALVE. IN (B)(6) 2024, THE PATIENT BEGAN COMPLAINING OF SHORTNESS OF BREATH AND FATIGUE. ON (B)(6) 2024, THE PATIENT WAS INFORMED THAT THE VALVE WAS FAILING AND NEEDED TO BE REPLACED DUE TO AORTIC STENOSIS AND CALCIFICATION. ON (B)(6) 2024, THE VALVE WAS EXPLANTED AND REPLACED WITH A NON-ABBOTT MECHANICAL HEART VALVE. THE TRIFECTA VALVE WAS NOTED TO BE CALCIFIED. THE PATIENT STATUS WAS STABLE AND DISCHARGED.

  Patient problems: Aortic Valve Stenosis; Atrial Fibrillation; Dyspnea; Fatigue; Heart Block; Hemothorax

  MAUDE report 20429135 ↗
• InjuryApr 1, 2024Calcified; Material Split, Cut or Torn; Calcified; Material Split, Cut or Torn

  USER FACILITY MEDWATCH REPORT MW5151234 RECEIVED THAT STATES " I HAD SEVERE CHEST PAIN AND RACING PULSE SO I WAS ADMITTED TO ER. IT WAS DETERMINED THAT I WAS IN SVT. AN ANGIOGRAM WAS PERFORMED AND ALSO ECHOCARDIOGRAM AND IT WAS DETERMINED THAT I HAD A FAILING AORTIC VALVE THAT HAD BEEN REPLACED IN (B)(6) OF 2017. THE VALVED WAS ONLY PERFORMING AT 25-30% ACCORDING TO DOCTORS. I HAD A ECHOGRAM IN LATE (B)(6) OF 2022 AND WAS SCHEDULED TO HAVE ANOTHER IN LATE (B)(6) OF 2023 BUT THIS ANTICIPATED THE APPOINTMENT. THE PREVIOUS ECHO HAD NO SIGNS OF FAILING VALVE. ONCE IT WAS DETERMINED THAT I REQUIRED A VALVE REPLACEMENT I STARTED RESEARCHING ISSUES WITH MY PREVIOUS VALVE ST. JUDE TRIFECTA 27MM WITH A SERIAL NUMBER OF (B)(6) AND LOT NUMBER 180097944, I WAS NOT AWARE OF ANY ISSUES AND THE ONLY WAY I KNEW WHAT DETAILS OF THE VALVE I HAD WAS BY REACHING OUT TO THE SURGEON TO GET THE SPECIFICS. I HAVE SINCE HAD TO HAVE THE VALVE REPLACED AND THAT WAS DONE (B)(6) OF 2023. I HAVE REPLACED IT WITH A MECHANICAL VALVE THE ON-X AORTIC VALVE. ANGIOGRAM SHOWED NO IMMEDIATE ISSUES AND THE ECHOGRAM SHOWED SEVERELY DAMAGED VALVE THE VALVE WAS CALCIFYING. IT WAS REPORTED THAT ON (B)(6) 2017, A 27MM TRIFEC

  Patient problems: Angina; Arrhythmia; Dyspnea; Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 19014761 ↗
• InjuryAug 24, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2016, A 27MM TRIFECTA VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. ON A LATER DATE, THE PATIENT PRESENTED WITH SEVERE SHORTNESS OF BREATH TO THE EMERGENCY DEPARTMENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL. ON (B)(6) 2023, THE VALVE WAS URGENTLY EXPLANTED AND REPLACED WITH AN UNKNOWN VALVE. THE EXPLANTED VALVE HAD A TEAR AT ONE OF THE COMMISSURES. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: Dyspnea

  MAUDE report 17612575 ↗
• InjuryApr 26, 2023Perivalvular Leak; Material Split, Cut or Torn; Perivalvular Leak; Material Split, Cut or Torn

  THE ABSTRACT ARTICLE, "TRIFECTA BIOPROSTHESES: EVALUATION OF THE SAFETY BASED ON THE STUDY OF DEGENERATIONS ACCORDING TO THE VARC-3 CLASSIFICATION", WAS REVIEWED. THE RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO EVALUATE THE INTRINSIC IMPUTABILITY OF TRIFECTA FOR DYSFUNCTION ACCORDING TO THE VARC-3 CLASSIFICATION IN PATIENTS IMPLANTED AND TO REASSESS THEIR REFERENCING IN OUR CENTER. TRIFECTA VALVE WAS THE DEVICE ASSOCIATED WITH THIS STUDY. THE ARTICLE CONCLUDED, THE CLASSIFICATION OF FAILURES ACCORDING TO VARC-3 INDICATED THE INTRINSIC IMPUTABILITY OF THE TRIFECTA¿ BIOPROSTHESES REGARDING TO THE NUMBER OF SVD-TYPE DYSFUNCTIONS. ALTHOUGH THIS STUDY HAS LIMITATIONS, IT SHOWS THE UNDERSTATEMENT OF MEDICAL-DEVICES-VIGILANCE CASES BY THE MEDICAL STAFF. [THE PRIMARY AUTHOR OF THIS ARTICLE IS RICHEZ, OPHELIE, AMIENS-PICARDIE UNIVERSITY HOSPITAL, 1 ROND-POINT DU PROFESSEUR CHRISTIAN CABROL, 80054 AMIENS, FRANCE, WITH EMAIL ADDRESS OF : [email protected]]. IT WAS REPORTED THAT IN (B)(6) 2015, A 21MM TRIFECTA VALVE WAS IMPLANTED DUE TO SEVERE CALCIFIED AORTIC STENOSIS AND SUDDEN ONSET DYSPNEA. POST-OP ULTRASOUND SHOWED THE TRIFECTA IN AORTIC POSITION WITH AN AVE

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Endocarditis; Pericardial Effusion

  MAUDE report 16817469 ↗
• InjurySep 29, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2015, A 27MM TRIFECTA VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. SEVEN YEARS LATER, THE VALVE WAS EXPLANTED DUE TO A LEAFLET TEAR AT THE STRUT OF THE VALVE. THE REPLACEMENT DEVICE IS UNKNOWN. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 15503563 ↗
• InjuryDec 1, 2020Backflow; Obstruction of Flow; Backflow; Obstruction of Flow

  ON AN UNKNOWN DATE A 27MM TRIFECTA VALVE WAS IMPLANTED. ON (B)(6) 2020, THE TRIFECTA VALVE WAS EXPLANTED, BECAUSE THE ECHO SHOWED INSUFFICIENCY AND DEGENERATION OF THE VALVE.

  Patient problems: Regurgitation, Valvular

  MAUDE report 10927287 ↗
• MalfunctionNov 20, 2020Backflow; Material Split, Cut or Torn; Backflow; Material Split, Cut or Torn

  ON (B)(6) 2015 A 27MM TRIFECTA VALVE WAS IMPLANTED. IN (B)(6) 2020 THE PATIENT CAME BACK TO CARDIOLOGIST COMPLAINING OF SHORTNESS OF BREATH AND AFTER EXAMINATION WITH ECHO, THE AORTIC REGURGITATION WAS OBSERVED. ON (B)(6) 2020 THE VALVE WAS EXPLANTED. UPON EXPLANTED A NON-CORONARY CUSP LEAFLET TEAR WAS DIAGNOSED. THE PROCEDURE WAS COMPLETED BY IMPLANTING A NON-ABBOTT VALVE (MAGNA EASE). THE PATIENT IS IN ICU. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT REMAINED STABLE THROUGH OUT AND POST PROCEDURE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea; Regurgitation, Valvular

  MAUDE report 10878391 ↗
• MalfunctionOct 22, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2016, A 27MM TRIFECTA VALVE WAS IMPLANTED. ON (B)(6) 2019, A 27MM TRIFECTA VALVE WAS EXPLANTED AND REPLACED WITH A PERCEVAL HEART VALVE. UPON EXPLANT, IT WAS FOUND THAT THERE WAS A TORN LEAFLET.

  Patient problems: Corneal Pannus; Cusp Tear

  MAUDE report 10723191 ↗
• InjuryMar 17, 2020Backflow; Infusion or Flow Problem; Backflow; Infusion or Flow Problem

  ON (B)(6) 2015, A 27MM TRIFECTA VALVE WAS SELECTED FOR IMPLANT IN THE PATIENT'S AORTIC POSITION. ON (B)(6) 2020, THE VALVE WAS EXPLANTED AFTER THE PATIENT PRESENTED WITH ACUTE AORTIC REGURGITATION. ECHOCARDIOGRAPHY SHOWED SEVERE TRANS - VALVULAR AORTIC REGURGITATION. A REPLACEMENT EDWARDS PERIMOUNT VALVE WAS IMPLANTED AND THE PATIENT WAS REPORTED TO BE STABLE AND RECOVERING.

  Patient problems: Aortic Regurgitation

  MAUDE report 9845102 ↗
• InjuryJan 30, 2020Backflow; Material Split, Cut or Torn; Backflow; Material Split, Cut or Torn

  ON(B)(6) 2014, A 27MM TRIFECTA VALVE WAS IMPLANTED. ON (B)(6) 2020, THE VALVE WAS EXPLANTED DUE TO SEVERE AORTIC INSUFFICIENCY. IT WAS ALSO REPORTED THAT THE PATIENT PASSED AWAY DURING EXPLANT OF THE TRIFECTA VALVE AND THE USER DOES ALLEGE A RELATIONSHIP BETWEEN THE PATIENT PASSING AND THE TRIFECTA VALVE.

  Patient problems: Aortic Insufficiency

  MAUDE report 9649673 ↗
• InjuryDec 27, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2015, A 27 MM TRIFECTA VALVE WAS IMPLANTED. IN (B)(6) 2019, THE PATIENT DEVELOPED SEVERE DYSPNEA AND UNDERWENT SEVERAL EXAMS. ECHO REVEALED MASSIVE REGURGITATION AND AN ABNORMAL LEAFLET MOTION. ON (B)(6) 2019, THE PATIENT UNDERWENT REDO SURGERY AND THE TRIFECTA VALVE WAS EXPLANTED. A CLEAR TEAR IN THE PERICARDIAL TISSUE NEXT TO THE STENT POST AND THE SUTURE LINE WAS OBSERVED UPON EXPLANT. A COMPETITOR'S 25 MM MAGNA EASE WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Dyspnea; Regurgitation

  MAUDE report 9526207 ↗
• InjuryNov 19, 2019Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn

  ON (B)(6) 2013, A 27MM TRIFECTA VALVE WAS IMPLANTED. ON (B)(6) 2019, THE DEVICE WAS EXPLANTED DUE TO A LOOSE OR TORN LEAFLET AND THE PATIENT WAS EXPERIENCING SHORTNESS OF BREATH. THE DEVICE WAS REPLACED WITH A 25MM INSPIRIS VALVE AND THE PATIENT IS REPORTED TO BE RECOVERING.

  Patient problems: Dyspnea; No Information

  MAUDE report 9344649 ↗
• InjuryJul 3, 2019Stretched; Incomplete Coaptation; Stretched; Incomplete Coaptation

  ON (B)(6) 2015, A 27MM TRIFECTA VALVE WAS IMPLANTED. ON (B)(6) 2019, THE PATIENT PRESENTED TO THE HOSPITAL WITH ANGINA PAIN AND UNDERWENT A CORONARY PROCEDURE. FOLLOWING THE CORONARY PROCEDURE, THE PATIENT DEVELOPED CARDIOGENIC SHOCK, ACUTE DECOMPENSATION WITH PULMONARY EDEMA AND CARDIAC ARREST. THE PATIENT WAS CARDIOVERTED AND STABILIZED. AN ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED AN INSUFFICIENCY. ON (B)(6) 2019, THE DEVICE WAS EXPLANTED. UPON EXPLANT, IT WAS OBSERVED THE NON-CORONARY CUSP (NCC) WAS STRETCHED RESULTING IN INCOMPLETE COAPTATION. THE VALVE WAS INTACT. THE DEVICE WAS REPLACED WITH A 25MM MAGNA EASE. POSTOPERATIVELY, THE PATIENT WAS HEMODYNAMICALLY STABLE, BUT THE PATIENT WAS SLOW TO WAKE, AGITATED, AND HAD DIFFICULTY MOVING THEIR LIMBS.

  Patient problems: Aortic Regurgitation; Chest Pain; Pulmonary Edema

  MAUDE report 8759976 ↗
• InjuryJan 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2013, A 27MM TRIFECTA VALVE WAS SUCCESSFULLY IMPLANTED. FIVE YEARS LATER ON (B)(6) 2018, THE DEVICE WAS EXPLANTED AS A RESULT OF AN UNSPECIFIED STRUCTURAL VALVE DETERIORATION (SVD). THE PATIENT IS REPORTED TO BE RECOVERING.

  Patient problems: Aortic Insufficiency

  MAUDE report 8222704 ↗
• InjuryDec 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2016, A 27MM TRIFECTA VALVE WAS IMPLANTED. DUE TO ACUTE BIOPROSTHESIS INSUFFICIENCY GRADE III, A VALVE-IN-VALVE PROCEDURE WITH A 26MM EDWARD SAPIEN 3 WAS COMPLETED ON (B)(6) 2018. THE PATIENT IS REPORTED DISCHARGED. PATIENT'S INFORMATION (E.G. AGE, WEIGHT, GENDER, ETHNICITY, RACE, PATIENT'S INITIALS) CANNOT BE HANDLED BY ABBOTT IN ABSENCE OF PATIENT'S WRITTEN CONSENT AS REQUIRED BY THE PERSONAL DATA PROTECTION NATIONAL LEGISLATION. NATIONAL LEGISLATION PREVENTS THE RECORDING OF SUCH INFORMATION. A WRITTEN CONSENT HAS NOT BEEN OBTAINED IN THIS CASE; THEREFORE, THIS INFORMATION IS NOT AVAILABLE.

  Patient problems: Aortic Insufficiency

  MAUDE report 8185157 ↗
• InjuryDec 18, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2016, A 27MM TRIFECTA VALVE WAS IMPLANTED. ON (B)(6) 2018, THE VALVE WAS EXPLANTED. UPON EXPLANT, A 3MM TEAR WAS OBSERVED AT THE NCC ALONG BOTH STENT POSTS THAT RESULTED IN PROLAPSE OF THE LEAFLET TO THE VENTRICLE. THE VALVE WAS REPLACED WITH A 27MM EDWARDS PERIMOUNT MAGNA EASE VALVE AND THE PATIENT IS REPORTED TO BE DISCHARGED.

  Patient problems: No Information

  MAUDE report 8177273 ↗
• InjuryNov 1, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2014, A 27MM TRIFECTA VALVE WAS IMPLANTED IN A (B)(6) PATIENT. FOLLOWING THE INITIAL VALVE REPLACEMENT, THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT WHICH BECAME INFECTED. THE PATIENT PRESENTED ON AN UNKNOWN DATE WITH SEVERE AORTIC REGURGITATION WHICH WAS INITIALLY CONSIDERED RELATED TO ENDOCARDITIS FOLLOWING AN INFECTED KNEE. ON (B)(6) 2018, THE 27MM TRIFECTA VALVE WAS EXPLANTED AND A 25MM EDWARDS MAGNA EASE WAS IMPLANTED, ALONG WITH A TRICUSPID VALVE REPAIR USING A 28MM PHYSIO RING. THERE WERE NO FINDINGS CONSISTENT WITH ACTIVE OR REMOTE ENDOCARDITIS; HOWEVER, THE NON-CORONARY CUSP OF THE TRIFECTA VALVE WAS OBSERVED DETACHED FROM THE COMMISSURE IN A LINEAR FASHION. THE PATIENT IS REPORTED DISCHARGED AND DOING WELL.

  Patient problems: Aortic Regurgitation

  MAUDE report 8029138 ↗
• InjuryAug 13, 2018Calcified; Calcified

  ON (B)(6) 2011, A 27 MM TRIFECTA VALVE WAS IMPLANTED. ECHOCARDIOGRAMS PERFORMED ON (B)(6) 2014 AND (B)(6) 2015 WERE NORMAL WITH NO SIGNS OF AORTIC REGURGITATION AND NORMAL AORTIC VALVE FUNCTION. ECHOCARDIOGRAM PERFORMED ON (B)(6) 2016 DEMONSTRATED TRACE OF AORTIC REGURGITATION. ON (B)(6) 2018, THE ECHO DEMONSTRATED MODERATE AORTIC REGURGITATION, MODERATE AORTIC VALVE STENOSIS, AND CALCIFICATION. THE PATIENT WAS HOSPITALIZED FROM 03 (B)(6) 2018 FOR DYSPNEA. AN ECHO PERFORMED ON (B)(6) 2018, NOTED SEVERE CALCIFICATION, MODERATE AORTIC VALVE STENOSIS (MAX PG 62 MMHG, MEAN PG 42 MMHG) AND MILD REGURGITATION. NO SIGNIFICANT VALVE DEFECTS WERE NOTED. ON (B)(6) 2018, THE PATIENT WAS DIAGNOSED WITH ENDOCARDITIS AND MEDICALLY TREATED. ON (B)(6) 2018, THE VALVE WAS EXPLANTED AFTER TREATMENT OF THE UNDERLYING ENDOCARDITIS AS THERE WAS CALCIFICATION. A 23 MM MAGNA EASE VALVE WAS IMPLANTED IN LIEU OF THE TRIFECTA VALVE. THE PATIENT IS REPORTED TO BE RECOVERING. THE VALVE WAS ANALYZED AT THE HOSPITAL AND NO ENDOCARDITIS WAS NOTED BUT A LEAFLET WAS ALMOST TORN OFF AT THE LEVEL OF THE NON CORONARY CUSP. THE VALVE WILL NOT BE RETURNED AS IT WAS DESTROYED BY EXAMINATION AT THE HOSPITAL. (CLINICAL ST

  Patient problems: Calcium Deposits/Calcification; Endocarditis

  MAUDE report 7779243 ↗
• InjuryJul 15, 2018Partial Blockage; Partial Blockage

  ON (B)(6) 2011, A 27 MM TRIFECTA VALVE WAS IMPLANTED. ON (B)(6) 2018, THE VALVE WAS EXPLANTED DUE TO STENOSIS AND AN EDWARDS LIFESCIENCES INSPIRIS VALVE WAS IMPLANTED. THE SURGEON REPORTED THE TRIFECTA WAS 7 YEARS OLD AT THE TIME OF EXPLANT. THE PATIENT IS REPORTED TO BE RECOVERING.

  Patient problems: Stenosis

  MAUDE report 7688539 ↗