CG FUTURERecalls & reported problems across all models
Medtronic, Inc. · 46 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 797
- Deaths reported
- 7
- Injuries reported
- 768
- Recalls
- 0
We found 46 models of CG FUTURE by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 797 adverse event reports in the FDA's MAUDE database, received between Dec 1, 2016 and Sep 30, 2026 — classified as 7 deaths, 768 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (542 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CG FUTURE problems
Device problems
- Insufficient Device Problem Information542
- Adverse Event Without Identified Device or Use Problem195
- Intravalvular regurgitation53
- Patient Device Interaction Problem47
- Inadequacy of Device Shape and/or Size45
- Break16
- Appropriate Device Problem Term/Code Not Available11
- Incomplete Coaptation11
Patient problems
- Insufficient Information348
- No Information244
- Mitral Regurgitation118
- Mitral Valve Insufficiency/ Regurgitation108
- No Known Impact Or Consequence To Patient26
- Mitral Valve Stenosis21
- Non specific EKG/ECG Changes18
- Mitral Insufficiency13
CG FUTURE models
46 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CG FUTURE™ 638BL32RING, ANNULOPLASTY1 death71 reports
- CG FUTURE™ 638BL30RING, ANNULOPLASTY1 death65 reports
- CG FUTURE™ 638RL32RING, ANNULOPLASTY59 reports
- CG FUTURE™ 638BL34RING, ANNULOPLASTY51 reports
- CG FUTURE™ 638RL30RING, ANNULOPLASTY1 death47 reports
- CG FUTURE™ 638BL28RING, ANNULOPLASTY1 death47 reports
- CG FUTURE® 638RL30RING, ANNULOPLASTY34 reports
- CG FUTURE® 638RL28RING, ANNULOPLASTY33 reports
- CG FUTURE™ 638RL28RING, ANNULOPLASTY33 reports
- CG FUTURE® 638BL32RING, ANNULOPLASTY32 reports
- CG FUTURE™ 638BL36RING, ANNULOPLASTY30 reports
- CG FUTURE® 638BL28RING, ANNULOPLASTY29 reports
- CG FUTURE™ 638RL34RING, ANNULOPLASTY1 death27 reports
- CG FUTURE® 638BL30RING, ANNULOPLASTY25 reports
- CG FUTURE™ 638BL38RING, ANNULOPLASTY21 reports
- CG FUTURE® 638BL26RING, ANNULOPLASTY2 deaths18 reports
- CG FUTURE® 638RL32RING, ANNULOPLASTY17 reports
- CG FUTURE® 638RL34RING, ANNULOPLASTY17 reports
- CG FUTURE® 638BL34RING, ANNULOPLASTY16 reports
- CG FUTURE® 638BL38RING, ANNULOPLASTY15 reports
- CG FUTURE® 638RL36RING, ANNULOPLASTY14 reports
- CG FUTURE™ 638BL26RING, ANNULOPLASTY14 reports
- CG FUTURE® 638BL36RING, ANNULOPLASTY12 reports
- CG FUTURE™ 638RL38RING, ANNULOPLASTY9 reports
- CG FUTURE® 638RL26RING, ANNULOPLASTY7 reports
- CG FUTURE™ 638RL26RING, ANNULOPLASTY7 reports
- CG FUTURE™ 638RL36RING, ANNULOPLASTY7 reports
- CG FUTURE® 638RL38RING, ANNULOPLASTY5 reports
- CG FUTURE® 638RL30RING, ANNULOPLASTY4 reports
- CG FUTURE® 638RL28RING, ANNULOPLASTY4 reports
- CG FUTURE® 638BL30RING, ANNULOPLASTY4 reports
- CG FUTURE® 638BL32RING, ANNULOPLASTY3 reports
- CG FUTURE® 638RL38RING, ANNULOPLASTY3 reports
- CG FUTURE® 638RL28RING, ANNULOPLASTY3 reports
- CG FUTURE® 638BL36RING, ANNULOPLASTY2 reports
- CG FUTURE® 638RL30RING, ANNULOPLASTY2 reports
- CG FUTURE® 638RL32RING, ANNULOPLASTY1 report
- CG FUTURE® 638BL38RING, ANNULOPLASTY1 report
- CG FUTURE® 638BL34RING, ANNULOPLASTY1 report
- CG FUTURE® 638BL28RING, ANNULOPLASTY1 report
- CG FUTURE® 638RL36RING, ANNULOPLASTY1 report
- CG FUTURE® 638BL36RING, ANNULOPLASTY1 report
- CG FUTURE® 638BL32RING, ANNULOPLASTY1 report
- CG FUTURE® 638BL30RING, ANNULOPLASTY1 report
- CG FUTURE® 638BL28RING, ANNULOPLASTY1 report
- CG FUTURE™ 638RL24RING, ANNULOPLASTY1 report
Recent CG FUTURE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Patient Device Interaction Problem
Medtronic received information that 1 month post implant of this 34mm tricuspid band and this 38mm mitral annuloplasty band, a Bi-Ventricular defibrillator was implanted. The reason for the Bi-Ventricular defibrillator was reported as low ejection fraction (EF). No additional adverse patient effects were reported.
Patient problems: Non specific EKG/ECG Changes
MAUDE report 50943042 ↗InjurySep 29, 2026Insufficient Device Problem Information
Medtronic received information that 4 days post implant of this 30mm mitral annuloplasty band, it was explanted and replaced with a 29mm mitral bioprosthetic valve. The reason for the replacement was not reported. No additional adverse patient effects were reported.
Patient problems: Insufficient Information
MAUDE report 50929527 ↗InjuryAug 23, 2026Intravalvular regurgitation
Medtronic received information that during the 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 during the patients mitral valve replacement patient's native posterior and anterior leaflet prolapse was addressed and the band was used to repair the patients mitral valve. It was reported after the repair an intraoperative transesophageal echocardiogram (TEE) showed a residual leak of 1.5 - 2+, and the physician determined that repair was not adequate, therefore the annuloplasty band was explanted and a 29mm mitral bioprosthetic valve was implanted. It was further reported post implant the transesophageal echocardiogram (TEE) showed no obvious paravalvular leak, and the mitral valve was functioning appropriately with no gradient across the mitral valve. It was further noted that the patient was discharged on (b)(6) 2026. No additional adverse patient effects were reported.
Patient problems: Mitral Valve Insufficiency/ Regurgitation
MAUDE report 50397246 ↗InjuryJul 27, 2026Patient Device Interaction Problem
It was reported that 3 days post implant of this 28mm mitral annuloplasty ring, a defibrillator was implanted. The reason for the de fibrillator was not reported. No additional adverse patient effects were reported.
Patient problems: Non specific EKG/ECG Changes
MAUDE report 50036815 ↗InjuryJul 27, 2026Insufficient Device Problem Information
Medtronic received information that during the implant of this 36mm mitral annuloplasty band, it was explanted and replaced with an unknown product. The reason for the replacement was not reported. No additional adverse patient effects were reported.
Patient problems: Insufficient Information
MAUDE report 50036261 ↗MalfunctionJul 15, 2026Incomplete Coaptation
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ANNULOPLASTY HEART BAND DID NOT MALFUNCTION AND IT WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 25824960 ↗InjuryJul 3, 2026Adverse Event Without Identified Device or Use Problem
MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 1 MONTHS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 25702437 ↗InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem
MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 11 MONTHS POST IMPLANT OF THIS 38 MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 30 MM MITRAL ANNULOPLASTY BAND OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 25677748 ↗InjuryJun 30, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT 2 YEARS AND 8 MONTHS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE AND 32MM AORTIC ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED
Patient problems: Heart Block
MAUDE report 25663628 ↗InjuryJun 29, 2026Intravalvular regurgitation
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM CG FUTURE MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 32MM CG FUTURE ANNULOPLASTY BAND. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MILD REGURGITATION CAUSED BY THE ANNULOPLASTY RING. IT WAS FURTHER NOTED THAT THE PATIENT'S ANNULUS MEASURED BETWEEN 31MM AND 33MM. AFTER SUTURING AND IMPLANT OF THE 32MM ANNULOPLASTY BAND, MILD REGURGITATION AND SYSTOLIC ANTERIOR MOTION (SAM) OCCURRED. THE 32MM ANNULOPLASTY BAND WAS EXPLANTED AND REPLACED WITH A VALVE PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Mitral Valve Insufficiency/ Regurgitation
MAUDE report 25651702 ↗InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem
MEDTRONIC RECEIVED INFORMATION THAT 8 MONTHS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 25634725 ↗InjuryJun 16, 2026Insufficient Device Problem Information; Intravalvular regurgitation
MEDTRONIC RECEIVED INFORMATION THAT 12 DAYS POST IMPLANT OF THIS 34MM CG FUTURE ANNULOPLASTY HEART BAND, IT WAS EXPLANTED AND REPLACED WITH A 40MM SIMUFORM SR HEART RING. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation; Obstruction/Occlusion
MAUDE report 25515497 ↗MalfunctionJun 11, 2026Incomplete Coaptation
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28 MM CG FUTURE ANNULOPLASTY HEART RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS SUBOPTIMAL LEAFLET COAPTATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 25470761 ↗MalfunctionJun 8, 2026Device Markings/Labelling Problem
MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION OF USE OF THIS 32MM ANNULOPLASTY BAND, IT WAS REPORTED THAT WHEN THE BARCODE ON THE PRODUCT PACKAGING WAS SCANNED BY THE HEALTHCARE PROFESSIONAL (HCP), AND THE DEVICE WAS CATEGORIZED AS A 34MM ANNULOPLASTY BAND IN THE HOSPITAL SYSTEM. THE 34MM SIZE DID NOT MATCH THE LABELED 32MM SIZE OF THE DEVICE. IT IS UNKNOWN IF A PATIENT WAS INVOLVED IN THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 25428430 ↗InjuryJun 5, 2026Intravalvular regurgitation
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURERS VALVE PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS AFTER IMPLANT, THE PATIENT STILL EXHIBITED SEVERE MITRAL REGURGITATION. THE ANNULOPLASTY RING WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Mitral Valve Insufficiency/ Regurgitation
MAUDE report 25411343 ↗
Other Medtronic, Inc. products
- CapSureFix Novus MRI SureScan29 models · 87,337 reports
- Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
- Intellis AdaptiveStim3 models · 35,469 reports
- SYNCHROMED II11 models · 32,260 reports · 4 recalls
- CAPSUREFIX NOVUS17 models · 27,547 reports
- INTERSTIM30 models · 24,415 reports · 1 recall
- Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page