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PROFILE 3D™ 680R26Recalls & reported problems

Medtronic, Inc. · RING 680R26 PROFILE 3D 26L · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994410344), received between Jun 14, 2022 and Jun 14, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Calcified” (1 report).

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

  • Adverse Event Without Identified Device or Use Problem1
  • Calcified1

Patient problems

  • Insufficient Information1
  • Mitral Valve Stenosis1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 14, 2022Calcified; Adverse Event Without Identified Device or Use Problem; Calcified; Adverse Event Without Identified Device or Use Problem

    MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 5 MONTHS POST IMPLANT OF THIS 26MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN MECHANICAL VALVE . THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: Insufficient Information; Mitral Valve Stenosis

    MAUDE report 14685090 ↗

Other RING, ANNULOPLASTY devices

All RING, ANNULOPLASTY devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.