Duran AnCoreRecalls & reported problems across all models
Medtronic, Inc. · 42 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 379
- Deaths reported
- 2
- Injuries reported
- 374
- Recalls
- 0
We found 42 models of Duran AnCore by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 379 adverse event reports in the FDA's MAUDE database, received between Nov 30, 2016 and Aug 23, 2026 — classified as 2 deaths, 374 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (276 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 Duran AnCore problems
Device problems
- Insufficient Device Problem Information276
- Adverse Event Without Identified Device or Use Problem75
- Patient Device Interaction Problem37
- Inadequacy of Device Shape and/or Size15
- Intravalvular regurgitation10
- Appropriate Device Problem Term/Code Not Available8
- Material Separation5
- Device Operates Differently Than Expected4
Patient problems
- Insufficient Information153
- No Information128
- Mitral Regurgitation44
- Mitral Valve Insufficiency/ Regurgitation27
- Mitral Valve Stenosis16
- Non specific EKG/ECG Changes16
- No Known Impact Or Consequence To Patient14
- Atrial Fibrillation10
Duran AnCore models
42 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Duran AnCore® 620BG35RING, ANNULOPLASTY36 reports
- Duran AnCore™ 620BG35RING, ANNULOPLASTY35 reports
- Duran AnCore™ 620BG33RING, ANNULOPLASTY29 reports
- Duran AnCore™ 620RG31RING, ANNULOPLASTY22 reports
- Duran AnCore® 620RG29RING, ANNULOPLASTY21 reports
- Duran AnCore® 620RG31RING, ANNULOPLASTY20 reports
- Duran AnCore™ 620BG31RING, ANNULOPLASTY1 death19 reports
- Duran AnCore® 620BG31RING, ANNULOPLASTY18 reports
- Duran AnCore® 620BG33RING, ANNULOPLASTY15 reports
- Duran AnCore® 620BG27RING, ANNULOPLASTY1 death13 reports
- Duran AnCore® 620RG27RING, ANNULOPLASTY12 reports
- Duran AnCore® 620BG29RING, ANNULOPLASTY12 reports
- Duran AnCore™ 620BG29RING, ANNULOPLASTY11 reports
- Duran AnCore™ 620RG29RING, ANNULOPLASTY9 reports
- Duran AnCore™ 620BG25RING, ANNULOPLASTY9 reports
- Duran AnCore™ 620BG27RING, ANNULOPLASTY9 reports
- Duran AnCore® 620RG25RING, ANNULOPLASTY8 reports
- Duran AnCore® 620RG33RING, ANNULOPLASTY7 reports
- Duran AnCore® 620RG35RING, ANNULOPLASTY7 reports
- Duran AnCore™ 620RG35RING, ANNULOPLASTY7 reports
- Duran AnCore® 620BG25RING, ANNULOPLASTY6 reports
- Duran AnCore® 620RG29RING, ANNULOPLASTY6 reports
- Duran AnCore™ 620RG27RING, ANNULOPLASTY5 reports
- Duran AnCore™ 620RG33RING, ANNULOPLASTY5 reports
- Duran AnCore® 620RG25RING, ANNULOPLASTY5 reports
- Duran AnCore® 620RG27RING, ANNULOPLASTY5 reports
- Duran AnCore® 620RG31RING, ANNULOPLASTY5 reports
- Duran AnCore® 620RG31RING, ANNULOPLASTY2 reports
- Duran AnCore® 620BG27RING, ANNULOPLASTY2 reports
- Duran AnCore® 620BG35RING, ANNULOPLASTY2 reports
- Duran AnCore® 620RG23RING, ANNULOPLASTY2 reports
- Duran AnCore™ 620RG25RING, ANNULOPLASTY2 reports
- Duran AnCore™ 620BG23RING, ANNULOPLASTY2 reports
- Duran AnCore® 620RG33RING, ANNULOPLASTY2 reports
- Duran AnCore® 620RG35RING, ANNULOPLASTY2 reports
- Duran AnCore® 620RG29RING, ANNULOPLASTY1 report
- Duran AnCore® 620RG31RING, ANNULOPLASTY1 report
- Duran AnCore® 620RG27RING, ANNULOPLASTY1 report
- Duran AnCore® 620BG33RING, ANNULOPLASTY1 report
- Duran AnCore® 620BG29RING, ANNULOPLASTY1 report
- Duran AnCore® 620BG27RING, ANNULOPLASTY1 report
- Duran AnCore® 620BG25RING, ANNULOPLASTY1 report
Recent Duran AnCore adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 23, 2026Insufficient Device Problem Information; Intravalvular regurgitation
Medtronic received information that 5 weeks post implant of this 35mm Duran AnCore annuloplasty heart band, it was explanted and replaced with a 31mm Duran AnCore annuloplasty 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
MAUDE report 50397522 ↗InjuryJul 29, 2026Patient Device Interaction Problem
It was reported that 2 years and 10 months post implant of this 31mm tricuspid annuloplasty ring and 31mm mitral bioprosthetic valve, a defibrillator was implanted. The reason for the defibrillator was reported as low ejection fraction (EF). No additional adverse patient effects were reported.
Patient problems: Non specific EKG/ECG Changes
MAUDE report 50065958 ↗InjuryJul 9, 2026Intravalvular regurgitation
IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 27MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 27MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS RESIDUAL MITRAL REGURGITATION. IT WAS NOTED THAT THE ANNULOPLASTY PRODUCT DID NOT MALFUNCTION AND THAT THE ANNULOPLASTY PRODUCT WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. IT WAS REPORTED THAT THE PATIENT DID HAVE PRE-EXISTING CONDITIONS/ANATOMICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Mitral Valve Insufficiency/ Regurgitation
MAUDE report 25760542 ↗InjuryJun 24, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT 7 MONTHS POST IMPLANT POST IMPLANT OF THIS 27 MM MITRAL ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS ATRIOVENTRICULAR BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED
Patient problems: Non specific EKG/ECG Changes
MAUDE report 25608758 ↗InjuryMay 21, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT 5 YEARS AND 6 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS INCOMPLETE ATRIOVENTRICULAR (AV) BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Non specific EKG/ECG Changes
MAUDE report 25243401 ↗InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 31 MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT PROVIDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 25122828 ↗InjuryApr 21, 2026Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 1 YEARS AND 9 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A NON MEDTRONIC PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 24940925 ↗InjuryMar 30, 2026Intravalvular regurgitation
IT WAS REPORTED THAT 3 YEARS AND 3 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 2 6MM MITRAL ANNULOPLASTY RING OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Mitral Valve Insufficiency/ Regurgitation
MAUDE report 24727360 ↗InjuryMar 6, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT 14 YEARS AND 9 MONTHS POST IMPLANT OF THIS 27MM AORTIC ANNULOPLASTY BAND, A 26MM TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 24529072 ↗InjuryFeb 13, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT 11 DAYS POST IMPLANT OF THIS 33 MITRAL ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS) AND ATRIAL ARRYTHMIAS ((ATRIAL TACHYCARDIA (AT), ATRIAL FIBRILLATION (AF) AND ATRIAL FLUTTER (A-FL). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Atrial Fibrillation; Atrial Flutter; Tachycardia
MAUDE report 24332023 ↗InjuryFeb 11, 2026Perivalvular Leak
IT WAS REPORTED THAT DURING THE IMPLANT OF THIS OF THIS 31MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A MITRAL VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS ENDO LEAK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Valvular Insufficiency/ Regurgitation
MAUDE report 24314131 ↗InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem; Intravalvular regurgitation
IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY RING, 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; Mitral Valve Insufficiency/ Regurgitation
MAUDE report 24277481 ↗InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT 1 YEARS AND 6 MONTHS POST IMPLANT OF THIS 33MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 35MM MITRAL ANNULOPLASTY BAND OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 24220673 ↗InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY 1 MONTH POST IMPLANT OF THIS 33MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 33MM MITRAL ANNULOPLASTY BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 24209195 ↗InjuryJan 5, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT 4 DAYS POST IMPLANT OF THIS 29MM MITRAL ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS ASYSTOLE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Asystole
MAUDE report 23955184 ↗
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.
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