CARBOMEDICS REDUCED R5-021Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08022057012777), received between May 25, 2017 and Sep 13, 2022 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2022Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER WAS INFORMED OF IMPLANT AND EXPLANT OF CARBOMEDICS TOP HAT MECHANICAL HEART VALVE , S5-021 THAT OCCURRED ON (B)(6) 2022. BASED ON THE INFORMATION PROVIDED, PRE-OPERATION, SIZING WAS PERFORMED AND IT WAS OKAY, THE PRODUCT WAS ALSO FINE. HOWEVER INTRA-OPERATION, THE LEAFLET WAS DETECTED TO BE STUCK. THE VALVE WAS THEN REPLACED WITH ANOTHER VALVE BUT SAME MODEL (S5-021). REPORTEDLY, PATIENT WAS STABLE THROUGH AND AFTER THE PROCEDURE. BASED ON FURTHER INFORMATION RECEIVED, NO MALFUNCTION WITH THE DEVICE WAS NOTED BEFORE THE PROCEDURE AND TESTING OF THE VALVE WAS OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15412233 ↗
• InjuryAug 18, 2020Fracture; Fracture

  THE MANUFACTURER WAS NOTIFIED OF AN EVENT INVOLVING BROKEN OR DETACHED VALVE LEAFLETS DURING AN ATTEMPT TO IMPLANT A CARBOMEDICS REDUCED AORTIC VALVE R5-021 ON (B)(6) 2020. NO OTHER DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10423726 ↗
• InjuryAug 18, 2020Fracture; Fracture

  THE MANUFACTURER WAS NOTIFIED OF AN EVENT INVOLVING BROKEN OR DETACHED VALVE LEAFLETS DURING AN ATTEMPT TO IMPLANT A CARBOMEDICS REDUCED AORTIC VALVE R5-021 ON (B)(6) 2020. NO OTHER DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10423725 ↗
• InjuryAug 18, 2020Fracture; Fracture

  ON (B)(6) 2020, A CARBOMEDICS REDUCED PROSTHESIS MODEL R5-021 WAS INTENDED FOR AN AORTIC VALVE REPLACEMENT. IT IS REPORTED THAT DURING THE SUTURING PROCEDURE, IT WAS NOTICED THAT ONE LEAFLET HAD BEEN BROKEN AND FELL FROM THE HINGE. PRIOR TO SUTURING THE VALVE NO DEVICE NOR LEAFLET MALFUNCTIONS WERE NOTED. ULTIMATELY, THE PATIENT RECEIVED A CARBOMEDICS STANDARD MODEL A5-021. THE PATIENT WAS NOT ADVERSELY IMPACTED BY THE EVENT AND WAS DISCHARGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10423174 ↗
• InjuryMar 26, 2020Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  ON (B)(6) 2020 A PATIENT WAS INTENDED TO RECEIVE A CARBOMEDICS R5-021 REDUCED AORTIC MECHANICAL HEART VALVE PROSTHESIS AS PART OF AN AVR WITH A CONCOMITANT MVR IN WHICH AN OPTIFORM F7-027 WAS IMPLANTED. THE MANUFACTURER WAS NOTIFIED THAT FIRST THE F7-027 WAS IMPLANTED IN MITRAL POSITION. THEN AORTIC VALVE WAS DECALCIFIED. ALTHOUGH A 23 MM SIZER FIT INTO THE ANNULUS, 21 MM CARBOMEDICS REDUCED VALVE WAS CHOSEN FOR THE AORTIC POSITION. FIRSTLY, SUTURES ON LEFT AND RIGHT CORONARY CUSP SIDE TIED AND WHILE THE SITE WAS WORKING ON NON CORONARY CUSP SIDE, THE SITE REALIZED THAT ONE OF LEAFLETS WAS BROKEN. THE VALVE WAS EXPLANTED AND THE SITE TOOK OUT PARTS OF THE LEAFLET WHICH HAD FALLEN INTO THE VENTRICLE. THE SITE IMPLANTED A 20 MM MEDTRONIC AP MECHANICAL VALVE AFTER CARBOMEDICS REDUCED WAS EXPLANTED. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD INDICATED THE FOLLOWING: WHAT WAS THE DELAY IN THE PROCEDURE AS A RESULT OF THIS ISSUE? THE TIME SPENT UNDER CROSS CLAMP. HOW WERE THE LEAFLETS BROKEN? WAS THIS A RESULT OF A PROCEDURAL ISSUE OR WERE THE LEAFLETS BROKEN PRIOR TO IMPLANTATION? THE LEAFLETS WERE BROKEN DURING STITCHING THE SUTURES ON NONCORONARY CUSP. THERE WASN¿T ANY PRESSURE OR

  Patient problems: Missing Value Reason

  MAUDE report 9884808 ↗
• InjuryMar 26, 2020Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  ON (B)(6) 2020 A PATIENT WAS INTENDED TO RECEIVE A CARBOMEDICS R5-021 REDUCED AORTIC MECHANICAL HEART VALVE PROSTHESIS AS PART OF AN AVR WITH A CONCOMITANT MVR IN WHICH AN OPTIFORM F7-027 WAS IMPLANTED. THE MANUFACTURER WAS NOTIFIED THAT FIRST THE F7-027 WAS IMPLANTED IN MITRAL POSITION. THEN AORTIC VALVE WAS DECALCIFIED. ALTHOUGH A 23 MM SIZER FIT INTO THE ANNULUS, 21 MM CARBOMEDICS REDUCED VALVE WAS CHOSEN FOR THE AORTIC POSITION. FIRSTLY, SUTURES ON LEFT AND RIGHT CORONARY CUSP SIDE TIED AND WHILE THE SITE WAS WORKING ON NON CORONARY CUSP SIDE, THE SITE REALIZED THAT ONE OF LEAFLETS WAS BROKEN. THE VALVE WAS EXPLANTED AND THE SITE TOOK OUT PARTS OF THE LEAFLET WHICH HAD FALLEN INTO THE VENTRICLE. THE SITE IMPLANTED A 20 MM MEDTRONIC AP MECHANICAL VALVE AFTER CARBOMEDICS REDUCED WAS EXPLANTED. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD INDICATED THE FOLLOWING: WHAT WAS THE DELAY IN THE PROCEDURE AS A RESULT OF THIS ISSUE? THE TIME SPENT UNDER CROSS CLAMP. HOW WERE THE LEAFLETS BROKEN? WAS THIS A RESULT OF A PROCEDURAL ISSUE OR WERE THE LEAFLETS BROKEN PRIOR TO IMPLANTATION? THE LEAFLETS WERE BROKEN DURING STITCHING THE SUTURES ON NONCORONARY CUSP. THERE WASN¿T ANY PRESSURE OR

  Patient problems: Missing Value Reason

  MAUDE report 9884784 ↗
• InjuryFeb 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO CARBOMEDICS REDUCED AORTIC VALVE R5-021 IMPLANTED ON (B)(6) 2016. IT WAS EXPLANTED AND REPLACED WITH A SIMILAR DEVICE BUT SMALLER SIZE R5-019 ON (B)(6) 2016. NO FURTHER EVENT DETAILS WERE PROVIDED AND VALVE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Information

  MAUDE report 8326634 ↗
• InjuryFeb 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO A CARBOMEDICS REDUCED AORTIC VALVE IMPLANTED ON (B)(6) 2014. IT WAS EXPLANTED AND REPLACED WITH A CARBOSEAL VALSALVA PROSTHESIS ON (B)(6) 2015. NO FURTHER EVENT DETAILS WERE PROVIDED.

  Patient problems: No Information

  MAUDE report 8318591 ↗
• InjuryDec 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  A CARBOMEDICS REDUCED AORTIC VALVE, R5-021, WAS IMPLANTED ON (B)(6) 2014. IN 2018, IT WAS REPORTED THAT THE VALVE WAS LEAKING, AND RE-OPERATION CANNOT BE PERFORMED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Aortic Regurgitation

  MAUDE report 8156871 ↗
• InjuryNov 13, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2015, THE PATIENT RECEIVED A CARBOMEDICS REDUCED AORTIC VALVE R5-021, SN # (B)(4) AS PART OF THE NATIVE AORTIC VALVE REPLACEMENT, ON (B)(6) 2018, THE PATIENT WAS OPERATED AGAIN TO HAVE THE DEVICE EXPLANTED AND REPLACED WITH ANOTHER CARBOMEDICS REDUCED AORTIC VALVE R5-021 ((B)(4)).

  Patient problems: No Information

  MAUDE report 8066791 ↗
• InjuryOct 23, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2018 A PATIENT RECEIVED A CARBOMEDICS REDUCED R5-021 AORTIC VALVE. THE SITE REPORTED THE VALVE WAS BROKEN AND FRAGMENTED FROM THE PIVOT PART AFTER THE SUTURES WERE ATTACHED IN THE AORTIC ANNULUS POSITION. ALL FRAGMENTS CAREFULLY WERE COLLECTED AND PATIENT WAS FLUSHED. SITE REPORTED ALL FRAGMENTS WERE REMOVED. ANOTHER CARBOMEDICS REDUCED R5-021 AORTIC VALVE WAS USED AS A REPLACEMENT. THIS EVENT ADDED 20 MINUTES TO THE X-CLAMP TIME.

  Patient problems: No Information

  MAUDE report 7997899 ↗
• InjuryAug 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014 A CARBOMEDICS REDUCED R5-021 MECHANICAL AORTIC VALVE WAS IMPLANTED. THE MANUFACTURER RECEIVED NOTIFICATION THAT ON (B)(6) 2018 A CARBOMEDICS TOP HAT S5-021 WAS IMPLANTED AT THE AORTIC POSITION. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 7835597 ↗
• InjuryMay 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2017, THE MANUFACTURER WAS NOTIFIED THAT A CARBOMEDICS MECHANICAL VALVE R5-021 WAS EXPLANTED AFTER 1.48 YEARS ON (B)(6) 2017. IT WAS IMPLANTED ON (B)(6) 2015.

  Patient problems: No Information

  MAUDE report 6593105 ↗