SJM™ SARP-26Recalls & reported problems
St. Jude Medical, Inc. · For Mitral Valve Repair · Class 2 · Implant
All models of SJM (31)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734007498), received between Sep 8, 2021 and Nov 21, 2023 — classified as 1 injury, 1 malfunction.
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. 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 Problem1
- Lack of Effect1
Patient problems
- Coagulation Disorder1
- Mitral Valve Insufficiency/ Regurgitation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2023Lack of Effect; Lack of Effect
IT WAS REPORTED THAT ON 23 OCTOBER 2023, A 26MM SEGUIN ANNULOPLASTY RING WAS SELECTED FOR AN IMPLANT. DURING SALINE TEST THE PHYSICIAN FOUND THE REPAIR WAS NOT ADEQUATE AS THERE WAS SEVERE MITRAL REGURGITATION GRADE-4. HE EXPLANTED THE RING AND REPLACED WITH A NON-ABBOTT MITRAL VALVE. THE PATIENT IS STABLE.
Patient problems: Mitral Valve Insufficiency/ Regurgitation
MAUDE report 18184083 ↗InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBSEQUENT TO THE INITIALLY FILED INFORMATION, THE FOLLOWING INFORMATION WAS RECEIVED ON (B)(6) 2021: IT WAS REPORTED THAT THE AFIBRINOGENEMIA DIAGNOSIS IN THIS EVENT WAS USED TO DOCUMENT TEMPORARY CHANGES IN FIBRINOGEN LEVELS IN THE BLOOD. THEREFORE THE INFORMATION REPORTED INITIALLY REMAINS A REPORTABLE EVENT.
Patient problems: Coagulation Disorder
MAUDE report 12438938 ↗
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- CG FUTURE™ 638BL30Medtronic, Inc. · RING, ANNULOPLASTY1 death65 reports
- CG FUTURE™ 638RL32Medtronic, Inc. · RING, ANNULOPLASTY59 reports
- Tri-Ad™ 900SFC228Medtronic, Inc. · RING, ANNULOPLASTY4 deaths56 reports
- CG FUTURE™ 638BL34Medtronic, Inc. · RING, ANNULOPLASTY51 reports
- Contour 3D® 690R30Medtronic, Inc. · RING, ANNULOPLASTY1 death50 reports
- CG FUTURE™ 638BL28Medtronic, 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 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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