COSGROVE-EDWARDS ANNULOPLASTY BAND WITH TEMPLATE/LANYARD 4600 (REF 460038MM)Recalls & reported problems
Edwards Lifesciences LLC · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00690103020571), received between Nov 12, 2021 and Nov 12, 2021 — classified as 1 injury.
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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Atrial Fibrillation1
- Inflammation1
- Insufficient Information1
- Purulent Discharge1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THROUGH IMPLANT PATIENT REGISTRY, IT WAS LEARNED THAT A PATIENT WITH A 38MM 4600 MITRAL RING WAS EXPLANTED AFTER AN IMPLANT DURATION OF THREE YEARS, FOUR MONTHS DUE TO PANNUS. THE EXPLANTED RING WAS REPLACED WITH A 31MM 7300TFX VALVE. PER THE MEDICAL RECORDS THE PATIENT PRESENTED WITH CVA, AN ECHO CONCERNING FOR TISSUE ON THE POSTERIOR ANULUS OF THE MV. THE PATIENT UNDERWENT EXPLANT OF THE 38MM 4600 MITRAL ANNULOPLASTY RING AND MVR WITH A 31MM 7300TFX VALVE. IT IS NOTED THE NATIVE MITRAL VALVE WITH ANNULOPLASTY RING HAD A THICK LAYER OF WHITE ENDOCARDIAL LIKE TISSUE THAT ENGULFED THE ANNULOPLASTY BAND AND EXTENDED DOWN THE LEAFLETS. WHERE THE P2-P3 SUB-COMMISSURE WOULD BE ON THE ANNULUS THE BAND WAS VISIBLE AND THERE WAS A BUBBLE OF PUS THAT WAS SENT FOR CULTURE. THERE WAS EXTENSIVE FIBROUS, INFLAMMATORY TISSUE. THE 31MM 7300TFX VALVE FUNCTIONED NORMALLY WITH GOOD LEAFLET MOTION AND NO PERIPROSTHETIC REGURGITATION. POD#2, ELECTROPHYSIOLOGY WAS CONSULTED FOR SYMPTOMATIC MOBITZ TYPE 1 AV BLOCK. POD #8, THE PATIENT DEVELOPED SLOW ATRIAL FIBRILLATION, AND THE DECISION WAS TO PROCEED WITH A PERMANENT PACEMAKER PLACEMENT ON POD #10. TISSUE SPECIMENS FROM THE OR SHOWED NO GROWTH AFTER SEV
Patient problems: Atrial Fibrillation; Inflammation; Insufficient Information; Purulent Discharge
MAUDE report 12804942 ↗
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- PROFILE 3D® 680R28Medtronic, Inc. · RING, ANNULOPLASTY1 death67 reports
- CG FUTURE™ 638BL30Medtronic, Inc. · RING, ANNULOPLASTY1 death65 reports
- CG FUTURE™ 638RL32Medtronic, Inc. · RING, ANNULOPLASTY59 reports
- Tri-Ad™ 900SFC228Medtronic, Inc. · RING, ANNULOPLASTY4 deaths56 reports
- CG FUTURE™ 638BL34Medtronic, Inc. · RING, ANNULOPLASTY51 reports
- Contour 3D® 690R30Medtronic, Inc. · RING, ANNULOPLASTY1 death50 reports
- CG FUTURE™ 638BL28Medtronic, Inc. · RING, ANNULOPLASTY1 death47 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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