Tendyne™ TENDV-RS2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067046192), received between Oct 6, 2025 and Oct 6, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Retraction 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2025Retraction Problem; Material Deformation; Retraction Problem; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 35M TENDYNE MITRAL VALVE LP WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, AFTER THE DEPLOYMENT OF VALVE, THE PATIENT DEVELOPED A VARIABLE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) GRADIENT (30-50MMMHG) THAT COULD NOT BE MITIGATED BY TENSION REDUCTION. THE PHYSICIAN DECIDED TO REMOVE THE VALVE. A TENDYNE GEN II RETRIEVAL SYSTEM HAS BEEN PREPARED BY INSTRUCTIONS FOR USE (IFU). A GOOD METAL TO METAL AND ALIGNMENT ACHIEVED BEFORE STARTING TO CAPTURE THE VALVE. WHEN ROTATING THE RETRIEVAL KNOB THE VALVE STARTED TO ENTER INTO THE SHEATH BUT THEN STOPPED DESPITE RETRIEVAL KNOB ROTATIONS. THE CATHETER BUCKLING HAS BEEN NOTICED AND NO PRESSURE APPLIED ON THE CATHETER BY THE PHYSICIAN DURING THE RETRIEVAL. THE RETRIEVAL HAS BEEN REMOVED AND A NEW TENDYNE GEN II RETRIEVAL SYSTEM HAS BEEN PREPARED FOLLOWING IFU. A GOOD METAL TO METAL AND ALIGNMENT ACHIEVED BUT, EXTREME RESISTANCE NOTICED DURING THE RETRIEVAL KNOB ROTATION AND THE KNOB WAS SPINNING BACK IF HAND REMOVED FROM THE WHEEL. THE CATHETER SHOWED SEVERE BOWING DURING VALVE RETRIEVAL. FINALLY THE VALVE HAS BEEN RETRIEVED. THE PATIENT HEMODYNAMIC WAS STABLE AND PATIENT AWAKE THE DAY AFTER. THE PATIENT WI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23222177 ↗
• MalfunctionOct 6, 2025Retraction Problem; Retraction Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23222174 ↗