Tendyne™ TENDV-LP-33SRecalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067032591), received between Oct 3, 2025 and Oct 3, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (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.
Reports received per month
Most reported problems
Device problems
- Off-Label Use1
- Perivalvular Leak1
Patient problems
- Hemolysis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 3, 2025Perivalvular Leak; Off-Label Use; Perivalvular Leak; Off-Label Use
IT WAS REPORTED THAT ON (B)(6) 2025, A 33S TENDYNE MITRAL VALVE LP WAS IMPLANTED WITH A SMALL TENDYNE APICAL PAD. ON (B)(6) 2025, A HEMOLYSIS HAD OCCURRED DUE TO PERIVALVULAR LEAK (PVL). ON (B)(6) 2025, A RE-TENSIONING WAS DONE SUCCESSFULLY. AND NO PVL LEFT.
Patient problems: Hemolysis
MAUDE report 23209220 ↗
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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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