SJM™ SARP-34Recalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734007535), received between Sep 14, 2021 and Apr 12, 2022 — classified as 2 injuries.
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
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Bradycardia1
- Pneumothorax1
- Tachycardia1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ON (B)(6) 2022, A 34MM SEMI-RIGID SADDLE WAS IMPLANTED. ON (B)(6) 2022, A PACEMAKER WAS IMPLANTED DUE TO BRADYCARDIA/TACHYCARDIA SYNDROME AND THE CAUSE OF THE BRADYCARDIA/TACHYCARDIA WAS UNKNOWN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2022.
Patient problems: Bradycardia; Tachycardia
MAUDE report 14082923 ↗InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ON (B)(6) 2021, A 34MM SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING WAS IMPLANTED. ON 28 (B)(6) 2021, A ROUTINE CHEST X-RAY WAS PERFORMED AND NOTED A PNEUMOTHORAX. ON (B)(6) 2021, THE PNEUMOTHORAX WAS DRAINED. IT IS THOUGHT THAT THE PNEUMOTHORAX WAS DUE TO A MINIMAL LESION ON LUNG THAT OCCURRED DURING THE PROCEDURE PREP WHILE PERFORMING A MINI THORACOTOMY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ((B)(4)).
Patient problems: Pneumothorax
MAUDE report 12468411 ↗
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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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