CARBOMEDICS REDUCED R5-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08022057012791), received between Dec 17, 2019 and Nov 21, 2024 — 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.

• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE MANUFACTURER WAS NOTIFIED BY A CARDIOLOGIST ABOUT A PATIENT WITH A CARBOMEDICS AORTIC MECHANICAL PROSTHESIS EXPERIENCING RECURRENT EMBOLIZATION. AS REPORTED, THE EMBOLIC EVENTS OCCURRED DESPITE EXCELLENT INR AND ABSENCE OF COAGULOPATHY DISORDERS. BASED ON THE INFORMATION RECEIVED, THERE IS NO VISIBLE DYSFUNCTION OF THE PROSTHESIS OR VALVE THROMBOSIS.

  Patient problems: Embolism/Embolus; Endocarditis

  MAUDE report 20746180 ↗
• InjuryOct 18, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE MANUFACTURER BECAME AWARE THROUGH DEVICE TRACKING INFORMATION THAT ON 29 JAN 2018, A CARBOMEDICS REDUCED AORTIC MECHANICAL HEART VALVE R5-025 WAS IMPLANTED AND THEN EXPLANTED INTRA-OPERATIVELY. AS FURTHER REPORTED, REASON FOR EXPLANT WAS THAT THE DEVICE DIDN'T POSITION WELL. IT WAS CONFIRMED THAT THERE WAS NO DEVICE MALFUNCTION IDENTIFIED AND NO ADDED TIME AS A RESULT OF THE EVENT. FURTHERMORE, THE MANUFACTURER WAS INFORMED THAT THE DECISION TO IMPLANT A BIOPROSTHESIS WAS TAKEN DURING THE SURGERY AND THE CARBOMEDICS VALVE WAS REPLACED WITH A SUTURED PERICARDIAL VALVE FROM A DIFFERENT MANUFACTURER (EDWARDS LIFESCIENCES 25MM 2800TFX). REPORTEDLY, THE PATIENT WAS STABLE THROUGHOUT THE SURGERY, WHICH WAS COMPLETED WITHOUT COMPLICATIONS AND A GOOD OUTCOME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20482308 ↗
• InjuryOct 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER BECAME AWARE THROUGH DEVICE TRACKING INFORMATION THAT ON (B)(6) 2018, A CARBOMEDICS REDUCED AORTIC MECHANICAL HEART VALVE R5-025 WAS IMPLANTED AND THEN EXPLANTED INTRA-OPERATIVELY. NO ALLEGATION OF DEVICE DYSFUNCTION NOR PATIENT INJURY HAS BEEN RECEIVED FROM THE HEALTHCARE FACILITY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20482070 ↗
• InjuryDec 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2020, A PATIENT WITH SEVERE AORTIC STENOSIS OF THE BICUSPID AORTIC VALVE AND ASCENDING AORTA DILATATION, RECEIVED A CARBOMEDICS REDUCED R5-025 IN AORTIC POSITION. THE PATIENT ALSO RECEIVED AN ASCENDING AORTA REPLACEMENT WITH A DACRON CONDUIT JOTEC 28MM DURING THE SAME PROCEDURE, WHICH WAS COMPLETED WITHOUT SURGICAL INCIDENTS. AFTER DECLAMPING THE AORTA, WITH THE PATIENT STILL UNDER CARDIOPULMONARY BYPASS (CPB), THE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) SHOWED A REGULAR FUNCTION OF THE PROTHESIS (MOTION OF BOTH LEAFLETS, NO SIGNIFICANT LEAKS). UPON WEANING FROM CPB, THERE WAS A SIGNIFICANT CLINICAL DETERIORATION. A NEW TEE WAS PERFORMED IN WHICH THERE WAS EVIDENCE OF DYSFUNCTIONAL LV, SEVERELY DILATED WITH SEVERE MI AND SEVERE INTRAPROSTHETIC AORTIC REGURGITATION. THE MOVEMENT OF ONE LEAFLET WAS CORRECTLY VISUALIZED BUT NOT THE OTHER. GIVEN THIS FINDINGS, A LEAFLET BLOCK WAS SUSPECTED. AS SUCH, THE AORTA WAS RE-CLAMPED, THE DACRON GRAFT WAS OPENED FOR EXPLORATION OF THE PROSTHESIS, AND IT WAS IDENTIFIED THAT ONE LEAFLET WAS MISSING. THE PROSTHESIS WAS REMOVED, THE LEFT VENTRICULAR CAVITY WAS CHECKED WITHOUT ANY FINDING, AND A NEW CARBOMEDICS REDUCED R5-025 WAS IMPLANTED.

  Patient problems: Aortic Insufficiency; Embolism

  MAUDE report 10963361 ↗
• InjuryDec 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2020, A PATIENT WITH SEVERE AORTIC STENOSIS OF THE BICUSPID AORTIC VALVE AND ASCENDING AORTA DILATATION, RECEIVED A CARBOMEDICS REDUCED R5-025 IN AORTIC POSITION. THE PATIENT ALSO RECEIVED AN ASCENDING AORTA REPLACEMENT WITH A DACRON CONDUIT JOTEC 28MM DURING THE SAME PROCEDURE, WHICH WAS COMPLETED WITHOUT SURGICAL INCIDENTS. AFTER DECLAMPING THE AORTA, WITH THE PATIENT STILL UNDER CARDIOPULMONARY BYPASS (CPB), THE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) SHOWED A REGULAR FUNCTION OF THE PROTHESIS (MOTION OF BOTH LEAFLETS, NO SIGNIFICANT LEAKS). UPON WEANING FROM CPB, THERE WAS A SIGNIFICANT CLINICAL DETERIORATION. A NEW TEE WAS PERFORMED IN WHICH THERE WAS EVIDENCE OF DYSFUNCTIONAL LV, SEVERELY DILATED WITH SEVERE MI AND SEVERE INTRAPROSTATIC AORTIC REGURGITATION. THE MOVEMENT OF ONE LEAFLET WAS CORRECTLY VISUALIZED BUT NOT THE OTHER. GIVEN THIS FINDINGS, A LEAFLET BLOCK WAS SUSPECTED. AS SUCH, THE AORTA WAS RE-CLAMPED, THE DACRON GRAFT WAS OPENED FOR EXPLORATION OF THE PROSTHESIS, AND IT WAS IDENTIFIED THAT ONE LEAFLET WAS MISSING. THE PROSTHESIS WAS REMOVED, THE LEFT VENTRICULAR CAVITY WAS CHECKED WITHOUT ANY FINDING, AND A NEW CARBOMEDICS REDUCED R5-025 WAS IMPLANTED. T

  Patient problems: Aortic Insufficiency; Embolism

  MAUDE report 10963284 ↗
• InjuryAug 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2017, CARBOMEDICS REDUCED VALVE R5-025 WAS IMPLANTED IN AORTIC POSITION. ON (B)(6) 2020, THE DEVICE WAS EXPLANTED AND REPLACED WITH A BICARBON SLIMLINE AORTIC VALVE ART23LSA. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 10393971 ↗
• InjuryAug 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2017, CARBOMEDICS REDUCED VALVE R5-025 WAS IMPLANTED IN AORTIC POSITION. ON (B)(6) 2020, THE DEVICE WAS EXPLANTED AND REPLACED WITH A BICARBON SLIMLINE AORTIC VALVE ART23LSA. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 10393965 ↗
• InjuryDec 17, 2019Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  ON (B)(6) 2013, A PATIENT RECEIVED A CARBOMEDICS REDUCED HEART VALVE R5-025 IN AORTIC POSITION. ON (B)(6) 2017, THE PATIENT EXPERIENCED A STROKE AND THE DEVICE IS REPORTED AS THE SUSPECTED CAUSE. ON (B)(6) 2017, THE DEVICE WAS EXPLANTED. THE PATIENT EXPERIENCED RIGHT HEMIPARESIS AND GLOBAL APHASIA FOLLOWING THIS EVENT. DESPITE THE EVENT REFERS TO A MALFUNCTIONING PROSTHESIS, THESE MALFUNCTIONS ARE NOT FURTHER SPECIFIED.

  Patient problems: Aortic Valve Stenosis; Endocarditis; Paresis; Stroke/CVA; Thromboembolism

  MAUDE report 9485365 ↗
• InjuryDec 17, 2019Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  ON (B)(6) 2013, A PATIENT RECEIVED A CARBOMEDICS REDUCED HEART VALVE R5-025 TO REPLACE THE NATIVE BICUSPID VALVE (PRE-OPERATIVE DIAGNOSIS: SEVERE AORTIC INSUFFICIENCY AND ANEURYSM OF THE ASCENDING AORTA). DURING THE SAME PROCEDURE, A LONGITUDINAL REDUCTION OF THE ASCENDING AORTA WAS ALSO PERFORMED. AN UNEVENTFUL POSTOPERATIVE COURSE WAS REPORTED AND AT DISCHARGE, A GOOD DEVICE FUNCTIONALITY WAS DETECTED. THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2017, THE PATIENT WAS HOSPITALIZED DUE TO STROKE, RIGHT HEMIPARESIS, AND GLOBAL APHASIA. THE EVENT IS REPORTEDLY LIKELY RESULTING FROM THROMBOEMBOLISM ORIGINATING FROM THE MECHANICAL VALVE. THE ECHO PERFORMED IN(B)(6) 2017 DETECTED THE PRESENCE OF PANNUS DEPOSITION ON THE PROSTHESIS, POSSIBLE THROMBUS DEPOSITIONS AND DYSFUNCTION OF THE PROSTHESIS (STENOSIS). ENDOCARDITIS WAS SUSPECTED DUE TO THE REPORTED SYMPTOMS OF FEVER. ON (B)(6) 2017, 4-WEEKS OF ANTIBIOTIC THERAPY WAS INITIATED TO STABILIZE THE CLINIC STATUS OF THE PATIENT. ON (B)(6) 2017, A RE-INTERVENTION WAS PERFORMED TO REPLACE THE MECHANICAL VALVE WITH A BIOLOGICAL PROSTHESIS. DURING THE PROCEDURE, A VENTRICLE-AORTIC DISCONNECTION WAS NOTED, SIMILAR TO PREVIOUS ENDOCARDITIS. THE

  Patient problems: Aortic Valve Stenosis; Endocarditis; Paresis; Stroke/CVA; Thromboembolism

  MAUDE report 9485269 ↗