Tri-Ad™ 900SFC236Recalls & reported problems
Medtronic, Inc. · BAND 900SFC236 TRI-AD2.0 ADAMS TRICUSPID · Class 2 · Implant
All models of Tri-Ad (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000102357), received between Jan 5, 2021 and Nov 14, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
- Patient Device Interaction Problem1
Patient problems
- Heart Block2
- Bradycardia1
- Tricuspid Valve Insufficiency/ Regurgitation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT APPROXIMATELY 1 MONTH POST-IMPLANT OF THIS 36MM TRICUSPID ANNULOPLASTY HEART BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Heart Block
MAUDE report 23555213 ↗InjuryJun 20, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 7 DAYS POST IMPLANT OF THIS 36MM TRICUSPID ANNULOPLASTY BAND, IT WAS REPORTED THAT AN ECHOCARDIOGRAM DISCOVERED 3RD DEGREE TRICUSPID INSUFFICIENCY AND COAPTATION DEFECT WITH RESTRICTION OF THE PATIENT'S NATIVE LEAFLET. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Tricuspid Valve Insufficiency/ Regurgitation
MAUDE report 17164125 ↗InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS 36MM TRICUSPID ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED IN THE PATIENT. THE REASON FOR THE PACEMAKER IMPLANT WAS REPORTED AS COMPLETE HEART BLOCK AND BRADYCARDIA. IT WAS ALSO REPORTED THAT THE PATIENT HAD A JUNCTIONAL ESCAPE RHYTHM IMMEDIATELY POST IMPLANT OF THE ANNULOPLASTY BAND THAT RESOLVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Bradycardia; Heart Block
MAUDE report 11115182 ↗
Other RING, ANNULOPLASTY devices
- CG FUTURE™ 638BL32Medtronic, Inc. · RING, ANNULOPLASTY1 death71 reports
- PROFILE 3D® 680R28Medtronic, Inc. · RING, ANNULOPLASTY1 death67 reports
- 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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