SJM Tailor™ TAB-29 (UDI 05414734055697)Recalls & reported problems
St. Jude Medical, Inc. · Annuloplasty Band · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734055697), received between Apr 14, 2021 and Jun 12, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Lack of Effect” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Lack of Effect1
Patient problems
- Dyspnea1
- Heart Failure/Congestive Heart Failure1
- Mitral Valve Insufficiency/ Regurgitation1
- Pleural Effusion1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2023Lack of Effect; Lack of Effect
IT WAS REPORTED THAT ON (B)(6) 2023, A 29MM TAILOR FLEXIBLE ANNULOPLASTY BAND WAS CHOSEN FOR IMPLANT. PRIOR TO IMPLANT, BLOOD FLOW WAS INTERRUPTED TO PLACE THE BAND. AFTER THE BAND WAS IMPLANTED, BLOOD FLOW WAS RELEASED, AND MITRAL VALVE SYSTOLIC ANTERIOR MOVEMENT (SAM) WAS CONFIRMED VIA ECHOCARDIOGRAM. THE TAILOR VALVE WAS REMOVED AND A 36MM NON-ABBOTT VALVE WAS IMPLANTED AS A REPLACEMENT.
Patient problems: Mitral Valve Insufficiency/ Regurgitation
MAUDE report 17110118 ↗InjuryApr 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2021, A 29MM TAILOR FLEXIBLE ANNULOPLASTY BAND WAS IMPLANTED. ON (B)(6) 2021, THE PATIENT PRESENTED WITH DYSPNEA AND A PLEURAL EFFUSION WAS NOTED. THE HEART LUNG MACHINE, PROCEDURE AND OVERALL PATIENT CONDITION (HEART FAILURE) CAUSED THE EFFUSION. A PLEURAL PUNCTURE WAS PERFORMED AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND SINCE HAS BEEN DISCHARGED.
Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure; Pleural Effusion
MAUDE report 11664221 ↗
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- Contour 3D® 690R30Medtronic, Inc. · RING, ANNULOPLASTY1 death50 reports
- CG FUTURE™ 638RL30Medtronic, Inc. · RING, ANNULOPLASTY1 death47 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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