CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS 7000TFX (REF 7000TFX27)Recalls & reported problems
Edwards Lifesciences LLC · Class 3 · 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 00690103167856), received between Oct 21, 2021 and Oct 21, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT THIS VALVE MODEL 7000TFX27 WAS EXPLANTED FROM THE MITRAL POSITION AFTER AN IMPLANT DURATION OF 12 YEARS FOR UNKNOWN REASON. A MITRIS RESILIA VALVE MODEL 11400M27 WAS IMPLANTED IN REPLACEMENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 12677702 ↗
Other replacement Heart-valve devices
- CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC 3300TFXEdwards Lifesciences LLC · replacement Heart-valve4 deaths671 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC 3300TFXEdwards Lifesciences LLC · replacement Heart-valve1 death656 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC 3300TFXEdwards Lifesciences LLC · replacement Heart-valve5 deaths533 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS 7300TFXEdwards Lifesciences LLC · replacement Heart-valve1 death425 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS 7300TFXEdwards Lifesciences LLC · replacement Heart-valve1 death391 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS 7300TFXEdwards Lifesciences LLC · replacement Heart-valve1 death290 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC 3300TFXEdwards Lifesciences LLC · replacement Heart-valve260 reports
- CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS 7300TFXEdwards Lifesciences LLC · replacement Heart-valve2 deaths229 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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