CARBOMEDICS ANNULOFLO AR-730Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08022057013682), received between Nov 29, 2018 and Mar 12, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH PATIENT TRACKING DATABASE. BASED ON THE INFORMATION RECEIVED FROM THE PATIENT IMPLANT FORM, ON (B)(6) 2020, THE ANNULOFLO MITRAL ANNULOPLASTY RING SIZE 30 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY FOR THE PATIENT WAS RECEIVED FROM THE HOSPITAL REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 13745368 ↗
• InjuryNov 29, 2018Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

  A MITRAL VALVE REPAIR WAS PERFORMED ON (B)(6) 2012. THE REPAIR WAS COMPLICATED, WITH CHORDS TO THE ANTERIOR LEAFLET, CLOSURE OF THE POSTERIOR MEDIAL COMMISSURE, AND IMPLANT OF A #30 CARBOMEDICS ANNULOFLO RING. AFTER A FEW YEARS, RECURRENT MITRAL REGURGITATION WAS IDENTIFIED, BUT THE PATIENT WAS DOING WELL, CLINICALLY. THE PATIENT BECAME MORE SYMPTOMATIC IN 2018, AND WAS ADMITTED FOR HEART FAILURE WITH DYSPNEA ON EXERTION. TEE PERFORMED ON (B)(6) 2018 REVEALED RING DEHISCENCE IN THE POSTERIOR LATERAL ASPECT OF THE RING, AND REGURGITATION FROM THAT AREA. THERE ALSO APPEARED TO BE A POSSIBLE FLAIL CHORD, BUT THIS WAS REPORTEDLY DIFFICULT TO CONFIRM. THE EJECTION FRACTION WAS NORMAL. MILD TRICUSPID REGURGITATION AND MILD DILATION OF THE RIGHT VENTRICLE WITH DECREASED RV CONTRACTILITY WERE PRESENT. REOPERATION WAS PERFORMED ON (B)(6) 2018 AND DEHISCENCE OF THE RING WAS CONFIRMED. THE RING AND REPAIR WERE OTHERWISE INTACT. THE VALVE WAS REPAIRED BY EXCISION OF THE RING AND EDGE-TO-EDGE REPAIR. A #32 CARBOMEDICS ANNULOFLEX RING WAS THEN IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Aortic Regurgitation; Dyspnea; No Information

  MAUDE report 8117651 ↗