TrifectaRecalls & reported problems across all models
St. Jude Medical, Inc. · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,083
- Deaths reported
- 76
- Injuries reported
- 967
- Recalls
- 0
We found 12 models of Trifecta by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,083 adverse event reports in the FDA's MAUDE database, received between Jun 15, 2018 and Sep 29, 2026 — classified as 76 deaths, 967 injuries, 40 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (385 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Trifecta problems
Device problems
- Material Split, Cut or Torn385
- Backflow173
- Calcified136
- Obstruction of Flow132
- Device Stenosis121
- Insufficient Device Problem Information115
- Intravalvular regurgitation106
- Incomplete Coaptation78
Patient problems
- Aortic Valve Insufficiency/ Regurgitation305
- Dyspnea246
- Aortic Valve Stenosis242
- Aortic Regurgitation123
- Aortic Insufficiency108
- Heart Failure/Congestive Heart Failure105
- Endocarditis77
- Insufficient Information77
Trifecta models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Trifecta™ TF-23Aheart-valve, non-allograft tissue22 deaths218 reports
- Trifecta™ TF-21Aheart-valve, non-allograft tissue12 deaths191 reports
- Trifecta™ TFGT-23Aheart-valve, non-allograft tissue7 deaths159 reports
- Trifecta™ TFGT-21Aheart-valve, non-allograft tissue12 deaths124 reports
- Trifecta™ TF-19Aheart-valve, non-allograft tissue5 deaths110 reports
- Trifecta™ TF-25Aheart-valve, non-allograft tissue9 deaths96 reports
- Trifecta™ TFGT-25Aheart-valve, non-allograft tissue5 deaths80 reports
- Trifecta™ TFGT-19Aheart-valve, non-allograft tissue3 deaths55 reports
- Trifecta™ TF-27Aheart-valve, non-allograft tissue20 reports
- Trifecta™ TFGT-27Aheart-valve, non-allograft tissue1 death18 reports
- Trifecta™ TFGT-29Aheart-valve, non-allograft tissue8 reports
- Trifecta™ TF-29Aheart-valve, non-allograft tissue4 reports
Recent Trifecta adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
DeathSep 29, 2026Material Split, Cut or Torn; Intravalvular regurgitation
It was reported that on (b)(6) 2018, a 21mm Trifecta GT Valve was chosen for implant. It was then reported on (b)(6) 2024, a decision was made perform redo-surgical aortic valve replacement due to severe aortic regurgitation and other unspecified heart problems. During intraoperative investigation, it was observed one of the Trifecta Valve leaflets had completely torn away. The 21mm Trifecta GT Valve was explanted and replaced with a 23mm non-Abbott valve. It was later reported the patient passed away on (b)(6) 2024.
Patient problems: Aortic Valve Insufficiency/ Regurgitation
MAUDE report 50940683 ↗InjurySep 25, 2026Insufficient Device Problem Information
It was reported that on (b)(6) 2017, a 23mm SJM Trifecta Valve was implanted for a aortic valve replacement procedure. On (b)(6) 2025, the patient required premature replacement. While attempting to close chest, the patient developed ventricular tachycardia and ventricular fibrillation and ultimately required placement of veno-arterial extracorporeal membrane oxygenation (VA-ECMO). The patient's chest remained open until (b)(6)2025. An automated implantable cardioverter-defibrillator was placed on (b)(6) 2025 prior to discharge the same day.
Patient problems: Insufficient Information
MAUDE report 50896836 ↗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 ↗DeathJun 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 21A MM TRIFECTA VALVE WAS IMPLANTED ON (B)(6) 2021. IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT PASSED AWAY. THE CAUSE OF DEATH IS UNKNOWN. NO FURTHER INFORMATION HAS BECOME AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 25537810 ↗DeathJun 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 21A MM TRIFECTA GT VALVE WAS IMPLANTED ON (B)(6) 2018. IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT PASSED AWAY. THE CAUSE OF DEATH IS UNKNOWN. NO FURTHER INFORMATION HAS BECOME AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 25526756 ↗InjuryJun 16, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT A 21 MM TRIFECTA GT VALVE WAS IMPLANTED ON (B)(6) 2018. IT WAS REPORTED THAT THE VALVE WAS EXPLANTED ON (B)(6) 2023. THE CAUSE OF THE EXPLANT IS UNKNOWN. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION HAS BECOME AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 25526447 ↗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 25MM TRIFECTA GT VALVE WAS IMPLANTED ON (B)(6) 2019. IT WAS REPORTED THAT THE VALVE WAS EXPLANTED ON 29 DECEMBER 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 25526375 ↗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 25MM TRIFECTA VALVE WAS IMPLANTED ON (B)(6) 2015. 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 25492055 ↗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 25MM TRIFECTA VALVE WAS IMPLANTED ON AN UNKNOWN DATE IN NOVEMBER OF 20123. IT WAS REPORTED THAT THE VALVE WAS EXPLANTED ON AN UNKNOWN DATE IN (B)(6) OF 2014. THE CAUSE OF THE EXPLANT IS UNKNOWN. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION HAS BECOME AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 25491958 ↗InjuryJun 12, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT A 23MM TRIFECTA VALVE WAS IMPLANTED ON (B)(6) 2016. 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 25491954 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- Durata28 models · 19,805 reports
- Assurity MRI2 models · 17,838 reports · 1 recall
- Gallant8 models · 12,885 reports · 5 recalls
- Quartet10 models · 11,001 reports
- MitraClip19 models · 9,056 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page