CG FUTURE® 638BL32 (UDI 00613994751782)Recalls & reported problems
Medtronic, Inc. · BAND 638BL32 CG FUTURE 10L INSERT · Class 2
All models of CG FUTURE (46)
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 00613994751782), received between Oct 21, 2024 and Oct 21, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Calcified” (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
- Calcified1
- Insufficient Device Problem Information1
- Intravalvular regurgitation1
- Patient Device Interaction Problem1
Patient problems
- Calcium Deposits/Calcification1
- Insufficient Information1
- Mitral Valve Insufficiency/ Regurgitation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 21, 2024Calcified; Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation; Calcified; Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation
MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT THE PATIENT HAD PRESENTED WITH A LOW LEFT VENTRICLE EJECTION FRACTION (EF) OF 20% AND ACUTE DECOMPENSATED HEART FAILURE PRIMARILY BASED ON ACUTE ONSET AORTIC VALVE REGURGITATION. IT WAS REPORTED THAT THE REASON FOR REPLACEMENT OF THE MITRAL BAND WAS SEVERE MITRAL VALVE REGURGITATION. IT WAS REPORTED THAT THE MITRAL ANNULOPLASTY BAND WAS INTACT BUT THERE WAS SEVERE MITRAL ANNULAR CALCIFICATION. IT WAS STATED THAT THE PATIENT IS DOING WELL.
Patient problems: Calcium Deposits/Calcification; Insufficient Information; Mitral Valve Insufficiency/ Regurgitation
MAUDE report 20492319 ↗
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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