Tendyne™ TENDV-LP-35MRecalls & reported problems
St. Jude Medical, Inc. · Mitral Valve · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067032621), received between Sep 26, 2025 and Dec 30, 2025 — classified as 1 death, 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Low Blood Pressure/ Hypotension1
- Thrombosis/Thrombus1
- Ventricular Fibrillation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DeathSep 26, 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 25MM TENDYNE MITRAL VALVE LP WAS CHOSEN FOR IMPLANT. DURING THE DEPLOYMENT OF A TENDYNE VALVE THE BLOOD PRESSURE OF THE PATIENT CRUSHED. PATIENT CONVERTED TO ON PUMP HEART SURGERY. AFTER SUCCESSFUL IMPLANTATION OF THE VALVE THE PATIENT WAS HEMODYNAMICALLY STABLE WITH NO CATECHOLAMINES. SUDDENLY THE PATIENT GOT VENTRICULAR FIBRILLATION (V-FIB) AND COULD NOT BEEN RESOLVED EVEN WITH MAXIMUM THERAPY. THE PATIENT WAS REPORTED PASSED AWAY. THE CAUSE OF DEATH WAS CARDIAC DEATH AFTER VENTRICULAR FIBRILLATION. THE IMPLANTER MENTIONED THE DEATH WAS RELATED TO VALVE BUT RELATED TO PROCEDURE.
Patient problems: Low Blood Pressure/ Hypotension; Ventricular Fibrillation
MAUDE report 23155115 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
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