Tendyne™ TENDV-LP-29SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05415067032652), received between Jul 1, 2025 and Sep 25, 2026 — classified as 1 death, 5 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Patient-Device Incompatibility

  It was reported that on (b)(6) 2026, a 29S Tendyne Mitral Valve LP was implanted in the patient. On (b)(6) 2026, the patient was hospitalized for endocarditis. The patient administered with antibiotics and no modification of the valve. The patient was reported recovering.

  Patient problems: Endocarditis

  MAUDE report 50897885 ↗
• DeathSep 1, 2026Patient Device Interaction Problem

  It was reported that on (b)(6) 2026, a 29mm Tendyne Mitral Valve was chosen for implant. Post-procedure, patient had experienced heart failure symptoms and required medication, Milrinone, before weaning off and recovering and in physiotherapy. On an unknown date, patient experienced unknown electrocardiogram (ECG) rhythm issues but it was unclear if previously placed epicardial pacer leads were used or effective in pacing the heart. It was then reported on (b)(6) 2026 the patient experienced cardiac arrest and was placed on extra corporeal membranous oxygen (ECMO) therapy on (b)(6) 2026. Post cardiac arrest, patient had severely depressed ejection fraction. A decision was made to place an Impella device to vent the left ventricle on (b)(6) 2026. On (b)(6) 2026, an echocardiogram noted the Tendyne Valve was significantly thrombosed while still on ECMO and with Impella. A decision was made to withdraw care and patient passed away on (b)(6) 2026.

  Patient problems: Cardiac Arrest; Heart Failure/Congestive Heart Failure; Non specific EKG/ECG Changes; Thrombosis/Thrombus

  MAUDE report 50548225 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 29S TENDYNE MITRAL VALVE LP WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVELS WERE APPROXIMATELY 300S. AN APEX BLEEDING WAS NOTED DURING IMPLANT AND A BLOOD TRANSFUSION WAS REQUIRED. THE CAUSE OF BLEEDING WAS RUPTURE OF PURSE STRINGS. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24332536 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ON (B)(6) 2025, A 29S TENDYNE MITRAL VALVE LP VALVE WAS CHOSEN FOR A PROCEDURE. THE VALVE WAS IMPLANTED IN A REGULAR WAY WITH GOOD VALVE FUNCTION AND NO INTERVENTIONAL GRADIENT. AFTER DEPLOYMENT, THE BLOOD PRESSURE WAS DECREASED AND CATECHOLAMINES WAS GIVEN TO KEEP PRESSURES UP. THERE WAS ASSUMPTION OF RETROPERITONEAL BLEEDING WAS EXCLUDED AFTER (COMPUTED TOMOGRAPHY (CT) SCAN (NO FINDINGS). THE PATIENT WAS PUT ON FEMORAL EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT AND TAKEN TO INTENSIVE CARE UNIT. ON (B)(6) 2025, THE PATIENT SHOWED COMPETENT TENDYNE VALVE FUNCTION BUT SUSPICION OF A ELEVATED LEFT VENTRICULAR OUTFLOW TRACT (LVOT) GRADIENT. THE ECMO COULD STILL NOT BE WEANED AND FURTHER FOLLOW-UP IS NEEDED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 23617256 ↗
• InjuryNov 14, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 29S TENDYNE MITRAL VALVE LP WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2025, A FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS CONDUCTED TO PREPARE FOR A LEFT ATRIAL APPENDAGE (LAA) ABLATION (EPU) A THROMBUS WAS FOUND STARTING FROM THE TENDYNE PROTHESIS INTO THE LAA. THE FORMER INTERNATIONAL NORMALIZED RATIO (INR) VALUES WERE USUALLY WITHIN THE RANGE IN BETWEEN 2.5-3.5. THE PATIENT WAS ON MARCUMAR (VITAMIN K ANTAGONIST). A FURTHER FOLLOW-UP UNDER HIGHER OAK DOSE WILL FOLLOW. THE PATIENT WAS REPORTED STABLE AT HOME AND A FOLLOW-UP TEE IN 2 MONTHS PLANNED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23555468 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(6) - SUMMIT, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 29MM TENDYNE MITRAL VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. THE PATIENT WAS ADMINISTERED PROTAMINE, NOREPINEPHRINE, VASOPRESSIN, AND 19000 IU OF HEPARIN FOR PROCEDURE. ON (B)(6) 2025, A TRANSTHORACIC ECHOCARDIOGRAM CONFIRMED A MODERATE CIRCUMFERENTIAL PERICARDIAL EFFUSION. THE PATIENT WAS HOSPITALIZED. ON (B)(6) 2025, THE PATIENT ALSO WENT INTO RATE CONTROLLED ATRIAL FIBRILLATION. THE DECISION WAS MADE TO PERFORM A PERICARDIOCENTESIS WITH DRAIN INSERTION. NO INTERVENTION WAS PERFORMED DUE TO THE ATRIAL FIBRILLATION. ON (B)(6) 2025, THE PATIENT SPONTANEOUSLY CONVERTED BACK TO SINUS RHYTHM. ON (B)(6) 2025, THE DRAIN WAS REMOVED. THE PATIENT WAS DISCHARGED AT THE TIME OF REPORT.

  Patient problems: Atrial Fibrillation; Pericardial Effusion

  MAUDE report 22373082 ↗