Duran AnCore® 620RG27 (UDI 00613994758941)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00613994758941), received between Dec 28, 2016 and Jan 6, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A HEART RING WAS IMPLANTED ON (B)(6) 2013. A NEW TISSUE VALVE WAS IMPLANTED ON (B)(6) 2019, WITH THE EXPLANTATION OF THE HEART RING OCCURRING DURING THE SAME PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 21077384 ↗
• InjuryMar 28, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation; Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL IN CARDIAC ARREST WITH CARDIOGENIC SHOCK. IT WAS STATED THAT THE PATIENT HAD EARLIER EXPERIENCED DIFFICULTIES BREATHING AND ABDOMINAL PAIN. IT WAS REPORTED THAT THE PATIENT WAS ASYSTOLIC AND ALSO EXPERIENCED PULSELESS ELECTRICAL ACTIVITY (PEA). CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. THE PATIENT WAS STABILIZED AND TRANSFERRED TO THE ICU. DURING THE PATIENTS STAY, THEY CONTINUED TO ARREST AND WAS HYPOTENSIVE AND REQUIRED VASOPRESSORS, INOTROPIC AND VENTILATORY SUPPORT. THE PATIENT HAD SEVERE LACTIC ACIDOSIS. IT WAS STATED THAT SEVERE MITRAL REGURGITATION AND DEHISCENCE OF THE MITRAL RING WAS OBSERVED ON A ECHOCARDIOGRAM. A COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN AND PELVIS WAS PERFORMED AND REVEALED PULMONARY CONGESTION/EDEMA, A MODERATE RIGHT SIDED PLEURAL EFFUSION, ABNORMAL HEPATIC ARCHITECTURE SUGGESTIVE FOR HYPOPERFUSION, WEDGE SHAPE INFARCTS OF BOTH KIDNEYS, THICKENED GALLBLADDER WALL, AND ASCITES. AN EXPLORATORY LAPAROTOMY AND REPLACEMENT OF THE MITRAL VALVE PROCEDURE WAS UNDERTAKEN. IT WAS NOTED THAT INTRA-OPERATIVELY, THE PATIENT'S BOWEL WAS FOUND TO BE WITHOU

  Patient problems: Abdominal Pain; Cardiac Arrest; Cardiogenic Shock; Dyspnea; Insufficient Information; Low Blood Pressure/ Hypotension; Mitral Valve Insufficiency/ Regurgitation; Pleural Effusion

  MAUDE report 18996287 ↗
• InjuryOct 18, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 9 MONTHS POST IMPLANT OF THIS 27MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 27MM 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; Mitral Valve Stenosis

  MAUDE report 12647696 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 27MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9207754 ↗
• InjuryAug 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT FOUR YEARS AND ONE MONTH POST IMPLANT OF THIS 27 MM MITRAL ANNULOPLASTY BAND, THE BAND WAS EXPLANTED AND REPLACED WITH A 29 MM BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Stenosis; No Information

  MAUDE report 7810257 ↗
• InjuryJul 20, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 2 MONTHS POST IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7707739 ↗
• InjuryApr 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THE MITRAL VALVE WAS INITIALLY REPAIRED WITH THIS 27MM MITRAL ANNULOPLASTY RING AND 6 GORE-TEX N EOCHORDAE PLACED TO THE P2 AND P3 POSTERIOR LEAFLETS. THE PHYSICIAN REPORTED THE VALVE SHOWED SENILE DEGENERATION AND CALCIFICATION OF THE RUPTURED CORDS. SEVERAL ANTERIOR LEAFLET STRUT CORDS WERE SIMILARLY AGED, THINNED, AND FRAGILE. THERE WAS A PAUCITY OF TISSUE IN THE P2 POSTERIOR LEAFLET REGION THAT WAS SUGGESTIVE OF OLD ENDOCARDITIS. THE VALVE FAILED HYDROSTATIC TESTING WITH MODERATE INSUFFICIENCY AND WAS THEREFORE REPLACED WITH A 27MM NON-MEDTRONIC BIOPROSTHETIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; Mitral Insufficiency

  MAUDE report 7469429 ↗
• InjuryOct 20, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS ANNULOPLASTY BAND, THE BAND WAS EXPLANTED AND REPLACED WITH A NON- MEDTRONIC VALVE FOR AN UNKNOWN REASON. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 6967342 ↗
• InjuryMar 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 8 YEARS POST IMPLANT OF THIS MITRAL ANNULOPLASTY BAND, THE PATIENT PRESENTED WITH A RUPTURED NEOCHORD WITH A PROLAPSED ANTERIOR LEAFLET. THERE WAS ALSO DILATION OF THE ANNULUS WITH INCOMPLETE COAPTATION OF THE ANTERIOR AND POSTERIOR LEAFLET. THE DEVICE WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Corneal Pannus; Mitral Valve Prolapse

  MAUDE report 6421283 ↗
• InjuryFeb 24, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS MITRAL ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. THE REASON FOR EXPLANT IS UNKNOWN. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6358495 ↗
• InjuryFeb 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING IMPLANT OF THIS ANNULOPLASTY RING IN THE MITRAL POSITION, THIS DEVICE WAS EXPLANTED AND REPLACED WITH A MECHANICAL PROSTHETIC HEART VALVE. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6327402 ↗
• InjuryDec 28, 2016Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT ONE YEAR POST IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE DEVICE WAS EXPLANTED AND REPLACED WITH A MITRAL BIOPROSTHETIC VALVE DUE TO SEVERE MITRAL REGURGITATION AND DEHISCENCE OF THE PREVIOUS VALVE REPAIR. A POST-OPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED NO MITRAL REGURGITATION. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 6209836 ↗