Trifecta™ TFGT-23ARecalls & reported problems

Summary

The FDA's MAUDE database contains 159 adverse event reports that list this exact device (DI 05415067018229), received between Jun 27, 2018 and Aug 24, 2026 — classified as 7 deaths, 145 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (60 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 25 most recent of 159 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on an Unknown date in (b)(6) 2017, a 23mm Trifecta GT Valve was implanted in the patient. On an Unknown date, it was reported that the patient expressed concerns that the valve was not functioning properly. The patient was then referred for a transcatheter procedure. However, the patient computed tomography (CT) scan and echocardiogram indicated that the transcatheter procedure might pose complications with a specific vein in her heart.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 50420913 ↗
• InjuryJun 18, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2019, A 23MM TRIFECTA GT VALVE WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2026, THE PATIENT PRESENTED WITH FATIGUE, EDEMA, CHEST PAIN, SHORTNESS OF BREATH (SOB), DIZZINESS AND HEARTBURN. THE VALVE GOT EXPLANTED. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Angina; Dyspnea; Fatigue; Movement Disorder; Pulmonary Edema

  MAUDE report 25552580 ↗
• InjuryJun 18, 2026Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2019, A 23MM TRIFECTA GT VALVE WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2024, THE VALVE GOT EXPLANTED DUE TO STENOSIS AND INSUFFICIENCY. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis

  MAUDE report 25552414 ↗
• InjuryJun 16, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 23MM TRIFECTA GT VALVE WAS IMPLANTED ON (B)(6) 2018. IT WAS REPORTED THAT THE VALVE WAS EXPLANTED ON (B)(6) 2026. THE CAUSE OF THE EXPLANT IS UNKNOWN. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION HAS BECOME AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25526377 ↗
• InjuryJun 16, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 23 MM TRIFECTA VALVE WAS IMPLANTED ON (B)(6) 2016. IT WAS REPORTED THAT THE VALVE WAS EXPLANTED ON (B)(6) 2025. THE CAUSE OF THE EXPLANT IS UNKNOWN. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION HAS BECOME AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25526205 ↗
• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 23MM TRIFECTA VALVE WAS IMPLANTED ON (B)(6) 2020. IT WAS REPORTED THAT THE VALVE WAS EXPLANTED ON(B)(6) 2025. THE CAUSE OF THE EXPLANT IS UNKNOWN. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION HAS BECOME AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25492029 ↗
• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 23MM TRIFECTA GT VALVE WAS IMPLANTED ON (B)(6) 2017. 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 25491036 ↗
• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 23A TRIFECTA GT VALVE WAS IMPLANTED ON (B)(6) 2017. IT WAS REPORTED THAT THE VALVE WAS EXPLANTED ON (B)(6) 2026. THE CAUSE OF THE EXPLANT IS UNKNOWN. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION HAS BECOME AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25488968 ↗
• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 23MMTRIFECTA VALVE WAS IMPLANTED ON (B)(6) 2017. IT WAS REPORTED THAT THE VALVE WAS EXPLANTED ON (B)(6) 2026. THE CAUSE OF THE EXPLANT IS UNKNOWN. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION HAS BECOME AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25487819 ↗
• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 23MM TRIFECTA GT VALVE WAS IMPLANTED ON (B)(6) 2026. 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 25487420 ↗
• DeathJun 3, 2026Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2018, A 23MM TRIFECTA GT HEART VALVE WAS IMPLANTED FOR SURGICAL AORTIC VALVE REPLACEMENT (SAVR). APPROXIMATELY FIVE YEARS POST-PROCEDURE IN 2023, THE PATIENT DEVELOPED RAPID AND SEVERE VALVE DYSFUNCTION OF THE TRIFECTA GT DEVICE. IN (B)(6) 2023, PATIENT WAS HOSPITALIZED FOR ACUTE CONGESTIVE HEART FAILURE WITH SEVERE AORTIC STENOSIS. A DECISION WAS MADE TO PERFORM REDO-SAVR ON (B)(6) 2023 WITH A 23MM EPIC PLUS SUPRA AORTIC VALVE. THE PATIENT'S POST-OPERATIVE COURSE WAS COMPLICATED BY CARDIOGENIC SHOCK REQUIRING INTRAVENOUS AORTIC BALLOON PUMP SUPPORT, PROGRESSIVE HYPOXIA, MULTIORGAN FAILURE, AND SEVERE THROMBOCYTOPENIA. COMFORT MEASURES WERE IMPLEMENTED DUE TO CRITICALLY POOR PROGNOSIS AND PATIENT PASSED AWAY ON (B)(6) 2023. THE DEATH CERTIFICATE IDENTIFIED PROSTHETIC AORTIC VALVE STENOSIS AS PART OF THE CAUSAL CHAIN LEADING TO DEATH.

  Patient problems: Aortic Valve Stenosis; Heart Failure/Congestive Heart Failure; Hypoxia; Shock; Thrombocytopenia

  MAUDE report 25382539 ↗
• InjuryNov 21, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2019, A 23MM TRIFECTA GT VALVE WAS IMPLANTED IN THE PATIENT. ON AN UNKNOWN DATE IN (B)(6) 2024, THE PATIENT BEGAN TO FEEL NUMBNESS IN THE HEART AND DIFFICULTY IN BREATHING. THE PATIENT GOT EXAMINED IN (B)(6) 2024 AND IT WAS FOUND THAT THE TRIFECTA VALCE HAD BECOME SO NARROWED THAT IT WAS BORDERLINE NON-FUNCTIONAL. A TRIPLEX EXAMINATION SHOWED THE VALVE HAD DETERIORATED TO A GREAT EXTENT AND IT WAS DETERMINED THAT IT WOULD NEED TO BE REPLACED. A NEW SURGERY OF REPLACING THE TRIFECTA WITH A MECHANICAL VALVE WAS SCHEDULED FOR BEGINNING OF 2025. HOWEVER, BECAUSE OF DIFFICULTY WITH BREATHING AND FAINTING EPISODES, IT WAS DECIDED THE SURGERY TO TAKE PLACE ON (B)(6) 2024. IT WAS FOUND THAT MORE THAN A LITTER OF FLUID HAD ACCUMULATED IN THE LUNGS DUE TO THE FACT THAT THE TRIFECTA HAD WORN OUT TO SUCH AN EXTENT THAT WAS ESSENTIALLY NON-FUNCTIONAL. AN UNKNOWN SIZE MECHANICAL VALVE WAS IMPLANTED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Angina; Dyspnea; Pleural Effusion; Syncope/Fainting

  MAUDE report 23618889 ↗
• InjuryOct 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2018, A 23MM TRIFECTA GT VALVE WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2024, AN EARLY STRUCTURAL VALVE DETERIORATION (SVD) WAS NOTED. THE VALVE SURGICALLY REMOVED AND REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 23323076 ↗
• InjurySep 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2022, A 23MM TRIFECTA GT VALVE WAS IMPLANTED IN THE PATIENT. THE ANNULAR DIMENSION OF THE NATIVE VALVE WAS 24MM (BASED ON PREOPERATIVE TRANSTHORACIC ECHOCARDIOGRAM (TTE) DATA. ON (B)(6) 2025, THE PATIENT EXPERIENCED CHEST TIGHTNESS, BACK PAIN, COLD SWEATS, AND CHEST PAIN. A ROUTINE ECHOCARDIOGRAPHIC EVALUATIONS WERE NOT PERFORMED; THE SYMPTOMS PROMPTED AN ECHOCARDIOGRAM, WHICH LED TO THE DIAGNOSIS OF STRUCTURAL VALVE DETERIORATION (SVD). ONE OF THE LEAFLETS HAD DETACHED. THE VALVE GOT EXPLANTED AND A NON-ABBOTT VALVE WAS IMPLANTED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Angina

  MAUDE report 23184389 ↗
• InjuryFeb 27, 2025Calcified; Patient-Device Incompatibility; Device Stenosis; Calcified; Patient-Device Incompatibility; Device Stenosis

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 23MM TRIFECTA GT VALVE WAS IMPLANTED. ON (B)(6) 2025, THE VALVE WAS EXPLANTED DUE TO SEVERE AND SYMPTOMATIC STENOSIS OF THE VALVE. THE STENT POSTS WERE "DENSELY ADHERENT TO THE WALL OF THE AORTA FOR ALL THREE POSTS. THE TRIFECTA VALVE LEAFLETS WERE VERY THICKENED WITH POOR MOBILITY AND HAD MULTIPLE CALCIUM DEPOSITS ON ALL THE LEAFLETS." THE PATIENT HAD ASSOCIATED SYMPTOMS OF SEVERE SHORTNESS OF BREATH WITH MINIMAL EXERTION (STAGE III+). THE PATIENT WAS REPORTED TO BE DOING "VERY WELL."

  Patient problems: Dyspnea

  MAUDE report 21480256 ↗
• InjuryOct 29, 2024Material Split, Cut or Torn; Intravalvular regurgitation; Material Split, Cut or Torn; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2018, A 23MM TRIFECTA GT VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. THE NATIVE AORTIC VALVE ANNULUS WAS MEASURED TO BE 24MM. AROUND (B)(6) 2020, THE PATIENT BEGAN TO EXPERIENCE PALPATIONS, AND MILD TO MODERATE AORTIC REGURGITATION WAS OBSERVED. AFTER MONITORING, THE CONDITION PROGRESSED DUE TO SEVERE REGURGITATION AROUND (B)(6) 2023. IN (B)(6) 2024, THE PLAN WAS MADE FOR REOPERATION. THE PATIENT WAS EXPERIENCING HEART FAILURE DUE TO SEVERE REGURGITATION AND STRUCTURAL VALVE DETERIORATION. ON (B)(6) 2024, THE VALVE WAS EXPLANTED AND REPLACED WITH A 23MM NON-ABBOTT VALVE. A LACERATION ON THE EXPLANTED VALVE WAS NOTED, WHICH EXTENDED FROM THE LEFT CORONARY CUSP (LCC)/RIGHT CORONARY CUSP (RCC) STENT POST TO THE LCC SIDE. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Heart Failure/Congestive Heart Failure

  MAUDE report 20558087 ↗
• InjuryOct 18, 2024Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2018, A 23MM TRIFECTA VALVE WAS IMPLANTED IN THE PATIENT. AFTER THE PROCEDURE, PATIENT HAVING EXERTIONAL WEAKNESS, FATIGUE AND DYSPNEA AND REQUIRED HOSPITALIZATION FOR ACUTE CONGESTIVE HEART FAILURE. ON (B)(6) 2023, AN ECHOCARDIOGRAPHY DEMONSTRATED MILD-MEDIUM AORTIC INSUFFICIENCY DUE TO VALVE DYSFUNCTION AND THE PATIENT PRESENTED WITH CARDIOGENIC SHOCK AND RESPIRATORY FAILURE. A TRANSCATHETER TRANSFEMORAL AORTIC VALVE IMPLANTATION WAS PERFORMED AND A 26MM NON-ABBOTT VALVE WAS IMPLANTED. THE PATIENT WAS RETUNED TO THE V-CRITICAL CARE UNIT IN CRITICAL CONDITION.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea; Fatigue; Heart Failure/Congestive Heart Failure; Respiratory Insufficiency; Shock

  MAUDE report 20487320 ↗
• InjuryOct 18, 2024Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2018, A 23MM TRIFECTA VALVE WAS IMPLANTED FOR AORTIC STENOSIS. ON (B)(6) 2023, PATIENT PRESENTED WITH HYPERTENSION (HTN) AND SEVERE AORTIC INSUFFICIENCY. A REDO-AORTIC VALVE REPLACEMENT WAS PERFORMED AND THE VALVE WAS REPLACED WITH A 23MM NON-ABBOTT VALVE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; High Blood Pressure/ Hypertension

  MAUDE report 20487318 ↗
• InjuryOct 18, 2024Calcified; Patient-Device Incompatibility; Device Stenosis; Calcified; Patient-Device Incompatibility; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2018, A 23MM TRIFECTA VALVE WAS IMPLANTED FOR SEVERE AORTIC STENOSIS. ON (B)(6) 2023, THE VALVE WAS EXPLANTED AND A NEW 21MM NON-ABBOTT VALVE WAS IMPLANTED. THE EXPLANTED VALVE WAS HEAVILY CALCIFIED WITH PANNUS GROWTH. THE PATIENT WAS REPORTED DISCHARGED ON (B)(6) 2023.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 20487254 ↗
• InjuryOct 18, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2017, A 23MM TRIFECTA GT VALVE WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2024, THE PATIENT PRESENTED WITH SEVERE AORTIC STENOSIS, AND A VALVE IN VALVE PROCEDURE PERFORMED WITH A 23MM NAVITOR VALVE AND MITRAL VALVE REPLACEMENT PERFORMED WITH A 23MM NON-ABBOTT VALVE. ON (B)(6) 2024, PATIENT HAD SEVERE STENOSIS, AND A VALVE IN VALVE PROCEDURE PERFORMED WITH A 29MM NON ABBOTT VALVE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 20487083 ↗
• InjuryOct 16, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2019, A 23MM TRIFECTA GT VALVE WAS IMPLANTED IN A PATIENT. ON (B)(6) 2024, THE VALVE WAS EXPLANTED. IT WAS REPORTED THAT THE VALVE WAS DEFECTIVE. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20463753 ↗
• InjurySep 19, 2024Degraded; Degraded

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AND YEAR, 23MM TRIFECTA GT FINAL PACKAGE - WR WAS IMPLANTED IN A PATIENT. ON AN UNKNOWN DATE AND YEAR, A THE PATIENT TRIFECTA HAD TO BE EXPLANTED AND REPLACED BECAUSE THERE WAS A PERFORATION. FURTHER INFORMATION IS NOT AVAILABLE AT THIS TIME. THE PATIENT IS STABLE.

  Patient problems: Perforation of Vessels

  MAUDE report 20257372 ↗
• InjurySep 13, 2024Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2018, A 23MM TRIFECTA GT VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. IN AUGUST 2022, AN ULTRASOUND OF THE PATIENT'S HEART DID NOT REVEAL ANY ISSUES. IN (B)(6) 2022, THE PATIENT EXPERIENCED SHORTNESS OF BREATH, DIFFICULTY URINATING, AND EXTREME FATIGUE. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT REPORTED THAT THEIR LUNGS HAD FLUID BUILDUP AND THAT THEIR ANKLES WERE SWOLLEN. DURING HOSPITALIZATION, THE PATIENT'S LUNGS WERE DRAINED. THE PATIENT WAS SENT HOME WITH A CATHETER AND REFERRED TO A NEPHROLOGIST FOR FURTHER ASSESSMENT. ON (B)(6) 2022, THE PATIENT EXPERIENCED EXTREME SHORTNESS OF BREATH AND APPEARED "GREY." THE PATIENT FELT WEAK AND FATIGUED. THE PATIENT WAS ADMITTED TO THE HOSPITAL, AND IT WAS REPORTED THAT THE PATIENT WAS IN AND OUT OF CONSCIOUSNESS. THE PATIENT WAS TOLD THAT THERE WAS BLOOD COMING OUT OF HER NOSE AND MOUTH, AND THE FAMILY WAS ADVISED THAT IT WAS THE AORTIC HEART VALVE. THE PATIENT ADDITIONALLY STATES THAT THERE WAS INTERNAL BLEEDING, WHICH WAS RESOLVED. ON (B)(6) 2022, THE PATIENT UNDERWENT A TRANSCATHETER AORTIC VALVE IMPLANTATION WITHOUT COMPLICATIONS. A 26MM NON-ABBOTT VALVE WAS IMPLANTED, AND IT WAS

  Patient problems: Anemia; Dyspnea; Fatigue; Heart Failure/Congestive Heart Failure; Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 20215577 ↗
• InjuryAug 1, 2024Device Stenosis; Device Stenosis

  USER FACILITY MEDWATCH REPORT MW5156222 RECEIVED THAT STATES "ON (B)(6) 2023 SAW CARDIOLOGIST FOR RECENT HOSPITALIZATION AND FINDING OF ABNORMAL BIOPROSTHETIC VALVE. STATUS POST 23 MM TRIECTA BIOPROSTHETIC VALVE PLACED ON (B)(6) 2018 AT (B)(6) BY (B)(6). RECEIVED NOTIFICATION LETTER JULY 2023 ABOUT TRIFECTA VALVE BEING CALLED OFF THE MARKET. HAD AN ECHO (B)(6) 2023 AND CARDIOLOGY VISIT ON (B)(6) 2023. READINGS FROM ECHO SHOWED FROM (B)(6) 2023 BIOPROSTHETIC VALVE GRADIENT HAS INCREASED FROM BASELINE. THE VALVE LEAFLETS ARE ABNORMALLY THICKENED. THE GRADIENT HAS INCREASED TO 37 MMHG WITH A PEAK VELOCITY OF 3.7 M/S. SYMPTOMS DOCUMENTED PROGRESSIVE EXERTIONAL DYSPNEA AND FATIGUE. NYLA CLASS II AND WORSENING. NEW DIAGNOSES OF BIOPROSTHETIC STRUCTURAL VALVE DEGENERATION. VALVE APPEARS ABNORMAL, GRADIENTS ARE SIGNIFICANTLY ELEVATED. I WAS REFERRED BACK TO (B)(6) FOR REDO SURGICAL CONSULT. ON (B)(6) 2024 I HAD AN ECHO TRANSTHORACIC IMPRESSIONS AORTIC VALVE PROSTHESES SYSTOLIC MEAN DOPPLER GRADIENT 43MMHG, EFFECTIVE ORIFICE AREA 0.94CM. COMPREHENSIVE OFFICE VISIT WITH (B)(6) ON (B)(6) 2024 WHERE REDO AORTIC VALVE REPLACEMENT WAS AGREED UPON. SURGERY OCCURRED ON (B)(6) 2024 WITH A DUAL PACE

  Patient problems: Aortic Valve Stenosis; Dyspnea; Fatigue; Heart Failure/Congestive Heart Failure

  MAUDE report 19883021 ↗
• InjuryJul 3, 2024Degraded; Degraded

  IT WAS REPORTED THAT ON (B)(6) 2018, A 23MM TRIFECTA GT VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. ON A LATER DATE, IT WAS DETERMINED THAT THE VALVE HAD SIGNIFICANTLY DETERIORATED. THE PATIENT REPORTEDLY SUFFERED FROM SIGNIFICANT HEALTH ISSUES. A TRANSCATHETER AORTIC VALVE WAS IMPLANTED. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19666356 ↗