PROFILE 3DRecalls & reported problems across all models

We found 11 models of PROFILE 3D by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 209 adverse event reports in the FDA's MAUDE database, received between Jan 17, 2017 and Jul 29, 2026 — classified as 3 deaths, 205 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (135 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

Most reported PROFILE 3D problems

PROFILE 3D models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PROFILE 3D® 680R28

  RING, ANNULOPLASTY
  1 death67 reports
• PROFILE 3D® 680R30

  RING, ANNULOPLASTY
  1 death40 reports
• PROFILE 3D® 680R32

  RING, ANNULOPLASTY
  31 reports
• PROFILE 3D® 680R26

  RING, ANNULOPLASTY
  24 reports
• PROFILE 3D® 680R34

  RING, ANNULOPLASTY
  16 reports
• PROFILE 3D® 680R36

  RING, ANNULOPLASTY
  1 death10 reports
• PROFILE 3D® 680R38

  RING, ANNULOPLASTY
  9 reports
• PROFILE 3D® 680R24

  RING, ANNULOPLASTY
  6 reports
• PROFILE 3D® 680R40

  RING, ANNULOPLASTY
  4 reports
• PROFILE 3D™ 680R26

  RING, ANNULOPLASTY
  1 report
• PROFILE 3D™ 680R28

  RING, ANNULOPLASTY
  1 report

Recent PROFILE 3D adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during the implant of this 32mm Profile 3D annuloplasty ring, it was explanted and replaced with an unknown device. The reason for the replacement was not reported. No additional adverse patient effects were reported.

  Patient problems: Insufficient Information

  MAUDE report 50065795 ↗
• InjuryJul 6, 2026Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 WEEKS POST IMPLANT OF THIS 28MM PROFILE 3D HEART RING, 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 25714965 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN UNKNOWN DURATION POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN U NKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24938397 ↗
• InjuryApr 21, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 1 YEAR AND 4 MONTHS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 24938302 ↗
• InjuryApr 14, 2026Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 11 MONTHS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, 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 24874298 ↗
• InjuryFeb 20, 2026Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE DID NOT MALFUNCTION AND THE DEVICE WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24399985 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 9 YEARS POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24344977 ↗
• InjuryDec 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 12 YEARS AND 1 MONTH POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS INCOMPLETE ATRIOVENTRICULAR BLOCK (AVB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23877954 ↗
• InjuryNov 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 8 YEARS POST IMPLANT OF THIS 32MM MITRAL HEART RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 23671247 ↗
• InjuryNov 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT POST IMPLANT OF THIS 26MM ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23657784 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 8 YEARS POST IMPLANT OF THIS 32MM ANNULOPLASTY HEART RING, 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 23655119 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 30MM ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN NEW HEART RING IN THE MITRAL POSITION. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23554313 ↗
• InjuryOct 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS AN UNSUCCESSFUL REPAIR. IT WAS REPORTED THAT THE ANNULOPLASTY PRODUCT MALFUNCTIONED AND WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23427597 ↗
• InjuryOct 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 9 YEARS AND 9 MONTHS POST IMPLANT OF THIS 28MM 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

  MAUDE report 23380389 ↗
• InjurySep 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 24MM PROFILE 3D HEART RING, 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 23027888 ↗

Other Medtronic, Inc. products

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