CARBOMEDICS REDUCEDRecalls & reported problems across all models

We found 6 models of CARBOMEDICS REDUCED by Corcym Srl in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between Nov 24, 2016 and Jan 7, 2026 — classified as 2 deaths, 35 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (26 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CARBOMEDICS REDUCED problems

CARBOMEDICS REDUCED models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CARBOMEDICS REDUCED R5-021

  HEART-VALVE, MECHANICAL
  13 reports
• CARBOMEDICS REDUCED R5-023

  HEART-VALVE, MECHANICAL
  2 deaths10 reports
• CARBOMEDICS REDUCED R5-025

  HEART-VALVE, MECHANICAL
  9 reports
• CARBOMEDICS REDUCED R5-019

  HEART-VALVE, MECHANICAL
  4 reports
• CARBOMEDICS REDUCED R5-029

  HEART-VALVE, MECHANICAL
  2 reports
• CARBOMEDICS REDUCED R5-027

  HEART-VALVE, MECHANICAL
  1 report

Recent CARBOMEDICS REDUCED adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED THROUGH DEVICE TRACKING ABOUT AN INTRA OPERATIVE EXPLANT OF A CARBOMEDICS REDUCED AORTIC VALVE R5-029 ON (B)(6) 2025. FURTHER INFORMATION CONFIRMED THAT VALVE WAS EXPLANTED INTRAOPERATIVELY. THE VALVE WAS EXPLANTED AS THE PATIENT UNDERWENT A HEART TRANSPLANT INSTEAD. NO DEVICE MALFUNCTION WAS IDENTIFIED. PATIENT RECOVERING WELL FOLLOWING HEART TRANSPLANT.

  Patient problems: Insufficient Information

  MAUDE report 23998687 ↗
• 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 19, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON (B)(6) 2023, A CARBOMEDICS REDUCED AORTIC VALVE R5-019 WAS IMPLANTED IN A PATIENT. AS REPORTED, THE "CONDITION WAS NOT GOOD", SO THE VALVE WAS EXPLANTED AND REPLACED WITH A LARGER VALVE R5-023 DURING THE SAME DAY. THE PATIENT IS DOING WELL. BASED ON THE FURTHER INFORMATION RECEIVED, THE PATIENT GOT BETTER AND HAS NO PROBLEM ANYMORE. THE MANUFACTURER WAS INFORMED THAT NO FURTHER INFORMATION WILL BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18361299 ↗
• InjuryJul 13, 2023Break; Break

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2023 A PATIENT UNDERWENT AORTIC VALVE REPLACEMENT WITH CARBOMEDICS REDUCED SIZE 23 MECHANICAL PROSTHESIS AND REPLACEMENT OF THE ASCENDING AORTA FOR THE TREATMENT OF AORTIC STENOSIS AND DILATATION OF THE AORTA. PATIENT'S NATIVE AORTIC VALVE WAS BICUSPID. AS REPORTED, WHILE APPLYING TRACTION ON THE MECHANICAL PROSTHESIS TO ADD A SUTURE AT THE END OF THE PROCEDURE, A BREAKING OF ONE OF THE LEAFLETS OCCURRED WHICH REQUIRED THE PROCEDURE TO BE REPEATED WITH A NEW PROSTHESIS. ANOTHER CARBOMEDICS REDUCED VALVE WAS CHOSEN AS REPLACEMENT DEVICE. WHILE RESTORING CARDIAC FUNCTION, THE PATIENT EXPERIENCED RECURRENT VENTRICULAR FIBRILLATION WHICH REQUIRED INFUSION OF CORDARONE 300 MG AND MAGNESIUM 2 G, RESUMPTION OF BYPASS SURGERY AND A NEW CARDIOPLEGIA. FINALLY, CARDIAC FUNCTION WAS SUCCESSFULLY RESTORED WITH EXTERNAL PACING AND NORADRENALINE 2MG/H. REPORTEDLY, THE PATIENT EXPERIENCED FRAGILITY OF THE NATIVE ANNULUS, CONDUCTIVE DISORDERS (BAV III WITH ESCAPE RHYTHM AT 50 BPM) AND CLAMPING TIME PROLONGATION (CEC TIME 146 MIN/AORTIC CLAMP TIME 120 MIN). DUE TO PERSISTENCE OF THE CONDUCTION DISTURBANCE POST-OPERATIVELY (BAV III DEGREE WITH AFIB) THE PA

  Patient problems: Insufficient Information

  MAUDE report 17314743 ↗
• 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 ↗
• InjuryMar 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH PATIENT TRACKING. THE TOP HAT SUPPRAANULAR VALVE SIZE 19, WHICH WAS IMPLANTED ON (B)(6) 2013, WAS EXPLANTED ON (B)(6) 2020 DUE TO SEVERE AORTIC STENOSIS AND VALVULAR DISEASE. THE ST. JUDE 21MM VALVE WAS IMPLANTED IN THE PATIENT INSTEAD. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 13772403 ↗
• 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 ↗
• InjuryNov 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED ON THE PATIENT IMPLANT FORM, A CARBOMEDICS REDUCED MECHANICAL VALVE R5-019 WAS IMPLANTED ON (B)(6) 2014 AND EXPLANTED ON (B)(6) 2020. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO INDICATION OF A DEVICE MALFUNCTION NOR SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: No Information

  MAUDE report 10805554 ↗
• InjuryNov 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED ON THE PATIENT IMPLANT FORM, A CARBOMEDICS REDUCED MECHANICAL VALVE R5-019 WAS IMPLANTED ON (B)(6) 2014 AND EXPLANTED ON (B)(6) 2020. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO INDICATION OF A DEVICE MALFUNCTION NOR SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: No Information

  MAUDE report 10805552 ↗
• 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 ↗

Other Corcym Srl products

• CARBOMEDICS SUPRA-ANNULAR (TOP HAT)5 models · 99 reports
• PERCEVAL PLUS4 models · 92 reports
• CARBOMEDICS STANDARD12 models · 83 reports
• MEMO 3D7 models · 54 reports
• CARBOMEDICS ANNULOFLEX6 models · 53 reports
• CARBOMEDICS OPTIFORM6 models · 37 reports
• MEMO 3D RECHORD6 models · 36 reports
• Memo 4D7 models · 29 reports