CARBOMEDICS ANNULOFLEX AF-836Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08022057013651), received between Dec 2, 2016 and May 7, 2021 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 RING AF-836 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 11794641 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; 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 RING AF-836 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11792564 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2019 A PATIENT WAS INTENDED TO RECEIVE A ANNULOFLEX AF-836. THE MITRAL VALVE WAS APPROACHED THROUGH A TRANSEPTAL INCISION. THE VALVE HAD SEVERE BILEAFLET PROLAPSE, BUT THE SIGNIFICANT PROLAPSING SEGMENT WAS THE P3 SEGMENT. INITIALLY SITE DID A COMMISSUROPLASTY FROM A3 TO P3 USING 4-0 PROLENE SUTURE IN A RUNNING FASHION. 11 POSTERIOR ANNULAR SUTURES PLACED AND DOWNSIZED THE ANNULUS TO A 36 POSTERIOR RING. HOWEVER, IT WAS CLEAR THAT AT THIS POINT, THE RING HAD DEFORMED THE ANNULUS DUE TO IT'S VERY LARGE SIZE. CONSEQUENTLY, THE SITE REMOVED THE RING. AT THIS POINT, THERE WAS EXCELLENT COMPETENCE OF THE VALVE WITH NO FURTHER PROLAPSE OR LEAKING. TOTAL CROSS CLAMP AND BYPASS TIME WERE 80 AND 90 MINUTES RESPECTIVELY. THE PATIENT TOLERATED THE PROCEDURE WELL AND HE WENT TO THE INTENSIVE CARE UNIT IN STABLE CONDITION.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 9433623 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6)2019 A PATIENT WAS INTENDED TO RECEIVE A ANNULOFLEX AF-836. THE MITRAL VALVE WAS APPROACHED THROUGH A TRANSEPTAL INCISION. THE VALVE HAD SEVERE BILEAFLET PROLAPSE, BUT THE SIGNIFICANT PROLAPSING SEGMENT WAS THE P3 SEGMENT. INITIALLY SITE DID A COMMISSUROPLASTY FROM A3 TO P3 USING 4-0 PROLENE SUTURE IN A RUNNING FASHION. 11 POSTERIOR ANNULAR SUTURES PLACED AND DOWNSIZED THE ANNULUS TO A 36 POSTERIOR RING. HOWEVER, IT WAS CLEAR THAT AT THIS POINT, THE RING HAD DEFORMED THE ANNULUS DUE TO IT'S VERY LARGE SIZE. CONSEQUENTLY, THE SITE REMOVED THE RING. AT THIS POINT, THERE WAS EXCELLENT COMPETENCE OF THE VALVE WITH NO FURTHER PROLAPSE OR LEAKING. TOTAL CROSS CLAMP AND BYPASS TIME WERE 80 AND 90 MINUTES RESPECTIVELY. THE PATIENT TOLERATED THE PROCEDURE WELL AND HE WENT TO THE INTENSIVE CARE UNIT IN STABLE CONDITION.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 9433583 ↗
• InjuryFeb 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO ANNULOFLEX MITRAL ANNULOPLASTY RING AF-836 IMPLANTED ON (B)(6) 2015 IN MITRAL POSITION. IT WAS EXPLANTED AND REPLACED WITH A CARBOMEDICS STANDARD PROSTHETIC MITRAL HEART VALVE M7-027 ON (B)(6) 2016. NO FURTHER EVENT DETAILS WERE PROVIDED AND DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Information

  MAUDE report 8329889 ↗
• InjuryJul 17, 2018Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ANNULOFLEX, SIZE 36, WAS IMPLANTED AND "REMOVED" ON (B)(6) 2018. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 7695120 ↗
• InjuryMar 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS NOTIFIED VIA PATIENT TRACKING THAT AN ANNULOFLEX RING, AF-836, WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. THE DEVICE WAS REPLACED WITH A SMALLER ANNULOFLEX RING, AF-834. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 7307219 ↗
• InjuryOct 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017 THE MANUFACTURER WAS NOTIFIED THROUGH PATIENT TRACKING OF A FAILURE TO IMPLANT ANNULOFLEX MITRAL ANNULOPLASTY RING AF-836 ON (B)(6) 2017. ON FOLLOW UP WITH THE SITE FURTHER INFORMATION WAS RECEIVED THAT DURING THE PROCEDURE THE PHYSICIAN NOTED THAT THE MITRAL VALVE REPAIR DID NOT TAKE AND THAT A MITRAL VALVE REPLACEMENT WAS REQUIRED. A MITRAL TISSUE VALVE WAS THEN IMPLANTED (MAKE/SIZE UNKNOWN).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6978447 ↗
• InjuryDec 2, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED A PATIENT TRACKING FORM ON 11-OCT-2016 OF THE FOLLOWING: A CARBOMEDICS ANNULOFLEX SN# (B)(4) WAS REMOVED FROM THE PATIENT ON (B)(6) 2016 AT (B)(6) AND THE DATE OF IMPLANT IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 6142447 ↗