Tendyne™ TENDV-LP-29LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067032669), received between Nov 7, 2025 and Dec 30, 2025 — classified as 2 deaths, 1 malfunction.

The most frequently reported specific device problem is “Device Stenosis” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 29L TENDYNE MITRAL VALVE LP WAS CHOSEN FOR IMPLANT IN THE PATIENT WHO HAD BEEN HOSPITALIZED PRIOR TO THE PROCEDURE. DURING PROCEDURE, THERE WERE NO COMPLICATIONS RELATED TO THE TENDYNE SYSTEM INCLUDING THE TENDYNE DELIVERY SYSTEM. THERE WAS SOME COMPLICATION WITH THE TRANS MITRAL ACCESS AND GETTING ABOVE THE MITRAL VALVE, HOWEVER THIS DID NOT LEAD TO HARM. THE VALVE WAS IMPLANTED. THE FOLLOWING DAY AFTER THE PROCEDURE ((B)(6) 2025), THE PATIENT WAS REPORTED PASSED AWAY. THE CAUSE OF DEATH WAS COMPLICATIONS FROM OTHER MEDICAL ISSUES. THE PHYSICIAN STATED THAT THE CAUSE OF DEATH WAS EXACERBATION OF OTHER DISEASE PROCESS AND NOT RELATED TO THE TENDYNE SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 23924551 ↗
• MalfunctionNov 18, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2025, A 29L TENDYNE MITRAL VALVE LP WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2025, THE VALVE SHOWED A THERAPY RESISTENT PEAK TO PEAK GRADIENT OF >40MMHG HAS DEVELOPED. THE TENDYNE VALVE SHOWS NO SIGNS OF MALFUNCTION OR DISPLACEMENT. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 23586116 ↗
• DeathNov 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  CLINICAL INFORMATION: (B)(6) - RESOLVE-MR STUDY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 29L TENDYNE MITRAL VALVE LP VALVE WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2025, A MASSIVE THROMBOSIS ON THE MITRAL VALVE PROTHESIS WAS NOTED. THE PATIENT REQUIRED PROLONGED HOSPITALIZATION DUE THIS EVENT. A CARDIAC SURGERY WAS CALLED AND THE PATIENT WAS TRANSFERRED WITH A DIAGNOSIS OF CARDIOGENIC SHOCK. THE PATIENT WAS REPORTED PASSED AWAY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23497000 ↗