CARBOMEDICS ANNULOFLEX AF-834Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08022057013644), received between Nov 26, 2018 and Sep 23, 2021 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2021, AN ANNULOFLEX ANNULOPLASTY MITRAL RING AF-834 WAS ATTEMPTED TO BE IMPLANTED. THE ANNULOFLEX AF-834 WAS CUT AT ANTERIOR CUT POINTS BY THE SITE CV RESIDENT. FRAYING OCCURRED AT A3-P3 PORTION OF RING. THE RING WAS DISCARDED. ANOTHER AF-834 RING WAS OPENED AND THIS TIME THE SURGEON REMOVED ANTERIOR PORTION BY CUTTING ANNULOFLEX ANTERIOR CUT POINTS. THERE WAS NO FRAYING OF RING AND THIS RING WAS IMPLANTED WITH NO INCIDENT. THE PROCEDURE WENT WELL WITH 10 MINUTES INCREASE IN CROSS-CLAMP TIME. THE PATIENT HAD NORMAL RECOVERY. BASED ON THE INFORMATION REPORTED BY THE PHYSICIAN, THE EVENT MAY BE DUE TO USE ERROR OCCURRING AT THE TIME OF THE REMOVAL OF THE ANTERIOR PORTION OF THE RING. -

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12522347 ↗
• MalfunctionSep 23, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2021, AN ANNULOFLEX MITRAL ANNULOPLASTY RING AF-834 WAS ATTEMPTED TO BE IMPLANTED. THE RING WAS CUT AT ANTERIOR CUT POINTS BY THE CV RESIDENT. FRAYING OCCURRED AT A3-P3 PORTION OF RING. THE RING WAS DISCARDED. ANOTHER AF-834 WAS OPENED AND THE SAME CV FELLOW REMOVED THE ANTERIOR PORTION BY CUTTING ANNULOFLEX ANTERIOR CUT POINTS. THERE WAS NO FRAYING OF RING, THAT WAS IMPLANTED WITH NO INCIDENT. THE PROCEDURE WENT WELL WITH 10 MINUTES INCREASE IN CROSS-CLAMP TIME. THE PATIENT HAD NORMAL RECOVERY. BASED ON THE INFORMATION REPORTED BY THE PHYSICIAN, THE EVENT MAY BE DUE TO USE ERROR OCCURRING AT THE TIME OF THE REMOVAL OF THE ANTERIOR PORTION OF THE RING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12522345 ↗
• InjuryMay 7, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURE WAS INFORMED OF THE EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, AN ANNULOFLEX ANNULOPLASTRY RING AF-834 WAS IMPLANTED AND EXPLANTED ON THE SAME DAY ON (B)(6) 2021. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 11793603 ↗
• InjuryMay 7, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  SEE INITIAL REPORT.

  Patient problems: Insufficient Information

  MAUDE report 11793579 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A MITRAL VALVE REPAIR WAS PERFORMED USING AN ANNULOFLEX AF-834 ANNULOPLASTY RING. SALINE TESTING FOLLOWING THE INITIAL ATTEMPT TO REPAIR THE VALVE REVEALED THAT THE VALVE WAS COAPTING TOO FAR ANTERIORLY. THE ANNULOPLASTY RING WAS THEREFORE REMOVED, AND A NEW ANNULOFLEX AF-824 WAS IMPLANTED. THE SECOND REPAIR WAS SUCCESSFUL. THE MITRAL VALVE WAS FUNCTIONING NORMALLY WITH TRACE INSUFFICIENCY, AND NO AORTIC INSUFFICIENCY WAS OBSERVED. THERE WAS NO SYSTOLIC ANTERIOR MOTION. HOWEVER, AFTER WEANING FROM BYPASS, THE PATIENT DETERIORATED HEMODYNAMICALLY DUE TO LIGATION OF THE CIRCUMFLEX CORONARY ARTERY. THE PROCEDURE WAS CONVERTED TO STERNOTOMY AND CABG WAS PERFORMED. AN IABP WAS ULTIMATELY IMPLANTED AND THE PATIENT WAS TRANSPORTED TO INTENSIVE CARE IN CRITICAL CONDITION.

  Patient problems: No Information

  MAUDE report 8375791 ↗
• InjuryFeb 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO ANNULOFLEX MITRAL ANNULOPLASTY RING AF-834, IMPLANTED ON (B)(6) 2015. IT WAS EXPLANTED AND REPLACED WITH AN OPTIFORM PROSTHETIC MITRAL HEART VALVE F7-031 ON (B)(6) 2016. NO FURTHER EVENT DETAILS WERE PROVIDED AND DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Information

  MAUDE report 8324297 ↗
• InjuryFeb 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO AN ANNULOFLEX MITRAL ANNULOPLASTY RING AF-834 IMPLANTED ON (B)(6) 2015. IT WAS EXPLANTED AND REPLACED WITH AN OPTIFORM PROSTHETIC MITRAL HEART VALVE F7-031 ON (B)(6) 2015. NO FURTHER EVENT DETAILS WERE PROVIDED.

  Patient problems: No Information

  MAUDE report 8318975 ↗
• InjuryNov 26, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AN ANNULOFLEX AF-834 WAS IMPLANTED AND EXPLANTED IN MITRAL POSITION INTRA-OPERATIVELY ON (B)(6) 2018. NO OTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Information

  MAUDE report 8104378 ↗