CG FUTURE® 638BL32 (UDI 00613994521118)Recalls & reported problems
Medtronic, Inc. · BAND 638BL32 CG FUTURE 10L · Class 2
Data updated Oct 13, 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 00613994521118), received between Feb 27, 2019 and Dec 6, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
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
- Insufficient Device Problem Information2
- Inadequacy of Device Shape and/or Size1
Patient problems
- Mitral Valve Insufficiency/ Regurgitation2
- Dyspnea1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 6, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 13 YEARS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS SEVERE MITRAL REGURGITATION. IT WAS STATED THAT THE MITRAL VALVE DEMONSTRATED RECURRENT PROLAPSE OF THE P2 SEGMENT DUE TO A SUTURE, PLACED AT THE TIME OF MITRAL REPAIR, HAVING PULLED THROUGH THE PAPILLARY MUSCLE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Mitral Valve Insufficiency/ Regurgitation
MAUDE report 15922940 ↗InjuryAug 19, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS 5 MONTHS POST IMPLANT OF THIS 32 MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS SEVERE MITRAL INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Mitral Valve Insufficiency/ Regurgitation
MAUDE report 15259516 ↗InjuryFeb 27, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
MEDTRONIC RECEIVED INFORMATION FROM A PATIENT THAT 8 DAYS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A LARGER BAND DUE TO "DIFFICULTY BREATHING". IT IS UNKNOWN IF THE REPLACEMENT BAND WAS MEDTRONIC OR A COMPETITOR. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Dyspnea
MAUDE report 8373805 ↗
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™ 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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