Trifecta™ TFGT-27ARecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05415067018243), received between Aug 27, 2018 and Jun 12, 2026 — classified as 1 death, 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 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) 2020. 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 25491516 ↗
• InjurySep 15, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2023, A 27MM TRIFECTA GT AORTIC VALVE WAS IMPLANTED SUCCESSFUL. ON (B)(6) 2025, IT WAS CONFIRMED THAT THE PATIENT WAS EXPERIENCING STRUCTURAL VALVE DETERIORATION IN THE FORM OF VALVE LEAKAGE, WHICH LED TO HEALTH ISSUES SHORTLY AFTER IMPLANTATION. SURGICAL INTERVENTION IS SCHEDULED FOR SEPTEMBER.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23058128 ↗
• InjuryAug 30, 2024Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2020, A 27MM TRIFECTA GT VALVE WAS SUCCESSFULLY IMPLANTED IN AN AORTIC VALVE REPLACEMENT. IN (B)(6) 2024, THE PATIENT BEGAN EXPERIENCING SYMPTOMS OF WEAKNESS AND FATIGUE. IN (B)(6) 2024, THE PATIENT WENT TO THE EMERGENCY DEPARTMENT DUE TO SYMPTOMS AND APPEARANCE OF PALENESS. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A LOW HEMOGLOBIN LEVEL OF 7.2. A SERIES OF TESTS WERE PERFORMED, AND NO UNDERLYING CAUSE WAS REPORTEDLY IDENTIFIED. FOUR DAYS LATER, THE PATIENT WAS DISCHARGED WITH FOLLOW UP APPOINTMENTS SCHEDULED WITH A HEMOTOLOGIST/ONCOLOGIST, DURING WHICH THE PATIENT RECEIVED MULTIPLE IRON INFUSIONS. ON (B)(6) 2024, THE PATIENT HAD A HEART CATHETERIZATION, WHICH REVEALED AORTIC VALVE REGURGITATION. THE PATIENT ALSO DEVELOPED AORTIC STENOSIS. THE PATIENT WAS TOLD THAT A TRANSCATHETER AORTIC VALVE IMPLANTATION WAS NECESSARY, AND THE PROCEDURE WAS SCHEDULED FOR (B)(6) 2024. THE PATIENT WAS REPORTED AS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Anemia; Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Fatigue; Insufficient Information

  MAUDE report 20105490 ↗
• InjuryMar 15, 2024Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2017, A 27MM TRIFECTA GT VALVE WAS SUCCESSFULLY IMPLANTED. DURING EARLY 2023, THE PATIENT EXPERIENCED PROBLEMS WITH A MURMUR, FATIGUE, ANEMIA, AND KIDNEY FUNCTION PARAMETERS. THE PATIENT MEASURED HIS BLOOD PRESSURE (BP) AT HOME WITH OMRON BP DEVICE, SHOWING THE DIASTOLIC BP TO BE FREQUENTLY AT 55 AND PULSE AS 57. THE VALVE TRANSITIONED FROM MILD LEAKAGE ON (B)(6) 2023 TO MODERATE LEAKAGE ON (B)(6) 2024. THE MODERATE LEAKAGE. AT ONE POINT, THE LEFT VENTRICULAR EJECTION FRACTION (LVEF) WAS <35% MEASURED BY ECHOCARDIOGRAM. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024, AND UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A NON-ABBOTT VALVE ON (B)(6) 2024.

  Patient problems: Anemia; Bradycardia; Fatigue; Heart Failure/Congestive Heart Failure; Low Blood Pressure/ Hypotension

  MAUDE report 18915016 ↗
• InjuryDec 28, 2023Degraded; Degraded

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AND YEAR, A 27MM TRIFECTA GT VALVE WAS IMPLANTED IN A PATIENT. AROUND (B)(6) 2023, THE PATIENT HAD HEART FAILURE-LIKE SYMPTOMS ON (B)(6) 2023, IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED WITH A MECHANICAL HEART VALVE DUE TO STRUCTURAL VALVE DETERIORATION. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18411091 ↗
• InjuryJun 26, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2017, A 27MM TRIFECTA GT FINAL PACKAGE WAS IMPLANTED IN A PATIENT. THE PATIENT HAD DYSPNEA AND COMPRESSIVE MID THORACIC PAIN ON EXERTION LASTING LESS THAN 5 MIN (ON EXERTION ONLY). MUST STOP WHEN WALKING. AMENDMENT OF SYMPTOMS AT REST.THERE WAS A RUPTURE OF ONE OF THE LEAFLETS OF THE AORTIC VALVE 5 YEARS AFTER IMPLANTATION. ON EXAMINATION IT APPEARED THAT THE AORTIC VALVE WAS WELL INSERTED. THERE WAS A TEAR IN THE RIGHT CORONARY SIGMOID ALONG THE STENT. NO SIGN OF INFECTION. ON (B)(6) 2023, A COMPLETE REMOVAL OF THE 27MM TRIFECTA GT TOOK PLACE, AS WELL AS AN AORTIC VALVE REPLACEMENT WITH A 27MM NON-ABBOTT DEVICE. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17200369 ↗
• InjuryJun 21, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2020, A 27MM TRIFECTA VALVE WAS SUCCESSFULLY IMPLANTED. APPROXIMATELY 2 MONTHS POST IMPLANT, THE PATIENT REPORTED SHORTNESS OF BREATH. ABOUT 2 AND A 1/2 YEARS POST IMPLANT, AORTIC INSUFFICIENCY WAS CONFIRMED, AND THE PHYSICIAN DECIDED TO EXPLANT THE VALVE DUE TO STRUCTURAL VALVE DETERIORATION. ON (B)(6) 2023, THE VALVE WAS SUCCESSFULLY EXPLANTED AND A 25MM EPIC PLUS VALVE WAS IMPLANTED AS A REPLACEMENT. A LEAFLET TEAR WAS OBSERVED ON THE EXPLANTED TRIFECTA VALVE. THE PATIENT WAS REPORTED AS RECOVERING.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea

  MAUDE report 17168188 ↗
• InjuryNov 30, 2022Insufficient Device Problem Information; Material Split, Cut or Torn; Intravalvular regurgitation; Insufficient Device Problem Information; Material Split, Cut or Torn; Intravalvular regurgitation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 27MM SJM TRIFECTA GT VALVE WAS IMPLANTED. ON (B)(6) 2022, THE VALVE WAS EXPLANTED DUE TO UNKNOWN REASONS. THE PATIENT STATUS WAS REPORTED AS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15889785 ↗
• InjuryOct 26, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2022, A 27MM TRIFECTA GT VALVE WAS IMPLANTED. IT WAS THEN DETERMINED THAT THE VALVE WAS NOT FUNCTIONING CORRECTLY, AND WAS EXPLANTED THE SAME DAY, ON (B)(6) 2022. A 25MM TRIFECTA GT WAS THEN SELECTED AND IMPLANTED AS A REPLACEMENT. IT WAS NOTED THAT THE 25MM TRIFECTA VALVE WAS FUNCTIONING AS INTENDED. THE PATIENT IS REPORTED TO HAVE DIED ON (B)(6) 2022. THE CAUSE OF DEATH IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED ON HOW THE 27MM TRIFECTA GT VALVE WAS NOT FUNCTIONING CORRECTLY.

  Patient problems: Insufficient Information

  MAUDE report 15671720 ↗
• MalfunctionJul 19, 2022Degraded; Degraded

  IT WAS REPORTED THAT IN 2020, A 27MM TRIFECTA GT VALVE WAS IMPLANTED. TWO YEARS POST-IMPLANT, MODERATE TRANSVALVULAR AORTIC REGURGITATION AND PREMATURE VALVE DEGENERATION WERE OBSERVED. IT WAS NOTED THAT THE PATIENT WOULD NEED CLOSE SURVEILLANCE AND MAY NEED FURTHER VALVE IMPLANT IN THE FUTURE. IT WAS REPORTED THAT THERE WAS NO ADVERSE EVENT TO THE PATIENT AT THE TIME OF REPORT.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 15056348 ↗
• InjuryMar 4, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED A 27MM TRIFECTA GT VALVE WAS IMPLANTED IN 2019. THE PATIENT WAS EXPERIENCING EPISODES OF DYSPNEA WHICH LED TO THE REMOVAL OF THE VALVE. ON (B)(6) 2022, THE VALVE WAS TRIFECTA GT VALE WAS EXPLANTED. UPON EXPLANT, THE VALVE WAS DESCRIBED TO HAVE A TORN LEAFLET FROM THE STENT. THE VALVE WAS REPLACED WITH A 25MM TRIFECTA GT VALVE. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND WAS RECOVERING POST PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea

  MAUDE report 13675823 ↗
• InjuryFeb 11, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED ON (B)(6) 2016, A 27MM TRIFECTA¿ GT VALVE WAS IMPLANTED. ON AN UNKNOWN DATE THE VALVE WAS EXPLANTED. THE REASON FOR THE EXPLANT IS UNKNOWN. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13515956 ↗
• InjurySep 9, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2020, A 27 MM TRIFECTA GLIDE TECHNOLOGY (GT) VALVE WAS IMPLANTED IN A PATIENT WITH A HISTORY OF HYPERTONIA. ON (B)(6) 2021, THE TRIFECTA GT VALVE WAS EXPLANTED. THE VALVE WAS EXPLANTED DUE TO LEAFLET RUPTURE FROM THE TOP OF THE STRUT TO THE BOTTOM OF THE LEAFLET. THE VALVE WAS REPLACED WITH A 27 MM NON-ABBOTT VALVE TO RESOLVE THE EVENT. THE PRE-OPERATIVE EXAMINATION SHOWED NO SIGNS OF ENDOCARDITIS. PATIENT'S ASSOCIATED SYMPTOMS ARE UNKNOWN. PATIENT IS REPORTED TO BE DOING WELL AND HAS BEEN TRANSPORTED TO ANOTHER HOSPITAL. NO ADDITIONAL INFORMATION AVAILABLE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 12448206 ↗
• InjuryAug 13, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2017, A 27MM TRIFECTA¿ GT VALVE WAS IMPLANTED. ON (B)(6) 2020, THE VALVE EXPLANTED DUE TO A LEAFLET TEAR THAT WAS NOTED ON AN ECHOCARDIOGRAM. THE VALVE WAS REPLACED WITH A ON-X PROSTHETIC HEART VALVE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10403400 ↗
• InjuryFeb 21, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2019, A 27MM TRIFECTA GT VALVE WAS IMPLANTED. ON (B)(6) 2020, THE PATIENT PRESENTED WITH COMPLAINTS INDICATIVE OF A LEAFLET TEAR, INCLUDING THORACIC COMPLAINTS AND EXERTIONAL DYSPNEA. ON (B)(6) 2020, THE VALVE WAS EXPLANTED AND REPLACED WITH A COMPETITOR'S EDW RESILIA VALVE, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT IS STABLE.

  Patient problems: Chest Pain; Dyspnea

  MAUDE report 9742098 ↗
• DeathJan 31, 2019Microbial Contamination of Device; Microbial Contamination of Device

  A PATIENT HAD A CRMD HIGH VOLTAGE DEVICE IMPLANTED ON (B)(6) 2013 WHICH WAS EXPLANTED ON (B)(6) 2018 WITH INFORMATION ON REPLACEMENT NOT MADE AVAILABLE. THEN ON (B)(6) 2017, THE PATIENT HAD A 33MM EPIC VALVE AND 27MM TRIFECTA GT IMPLANTED. ON AN UNKNOWN DATE, THE PATIENT WAS REPORTED WITH ENDOCARDITIS AND DIAGNOSED WITH SEPSIS. ON (B)(6) 2018, THE PATIENT PASSED AWAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Death; Endocarditis; Sepsis

  MAUDE report 8294936 ↗
• InjuryNov 13, 2018No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2017, A 27MM TRIFECTA GT VALVE WAS IMPLANTED. ON (B)(6) 2017, THE PATIENT PRESENTED SHORT EPISODES OF PARODISTIC ATRIAL FIBRILLATION THAT WAS TREATED WITH AMIODARONE VIA IV. ON (B)(6) 2017, THE PATIENT WAS DISCHARGED. (CLINICAL STUDY PATIENT ID: (B)(6))

  Patient problems: Atrial Fibrillation

  MAUDE report 8063803 ↗
• InjuryAug 27, 2018Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2018, A 27MM TRIFECTA GT VALVE WAS SELECTED FOR IMPLANT, THE VALVE WAS REMOVED FROM ITS ORIGINAL VALVE JAR AND PLACED IN NACL SOLUTION TILL THE SURGEON WAS READY TO IMPLANT. AFTER IMPLANTING THE VALVE AND CLOSING THE AORTA, A TEE WAS PERFORMED, WHICH REVEALED COMPLETE INSUFFICIENCY OF ALL THREE LEAFLETS. THE DEVICE WAS EXPLANTED AND EXCHANGED FOR A 27MM EDWARDS PERIMOUNT VALVE. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Information

  MAUDE report 7818620 ↗