CARBOMEDICS STANDARDRecalls & reported problems across all models

We found 12 models of CARBOMEDICS STANDARD by Corcym Srl in the FDA's device registry (GUDID). Together they are named in 83 adverse event reports in the FDA's MAUDE database, received between Mar 4, 2016 and Dec 4, 2025 — classified as 4 deaths, 71 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (43 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 STANDARD problems

CARBOMEDICS STANDARD models

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

• CARBOMEDICS STANDARD M7-027

  HEART-VALVE, MECHANICAL
  2 deaths15 reports
• CARBOMEDICS STANDARD M7-025

  HEART-VALVE, MECHANICAL
  1 death12 reports
• CARBOMEDICS STANDARD A5-023

  HEART-VALVE, MECHANICAL
  11 reports
• CARBOMEDICS STANDARD A5-025

  HEART-VALVE, MECHANICAL
  9 reports
• CARBOMEDICS STANDARD M7-031

  HEART-VALVE, MECHANICAL
  9 reports
• CARBOMEDICS STANDARD M7-029

  HEART-VALVE, MECHANICAL
  8 reports
• CARBOMEDICS STANDARD A5-021

  HEART-VALVE, MECHANICAL
  5 reports
• CARBOMEDICS STANDARD M7-033

  HEART-VALVE, MECHANICAL
  5 reports
• CARBOMEDICS STANDARD A5-016

  HEART-VALVE, MECHANICAL
  3 reports
• CARBOMEDICS STANDARD A5-019

  HEART-VALVE, MECHANICAL
  1 death2 reports
• CARBOMEDICS STANDARD A5-029

  HEART-VALVE, MECHANICAL
  2 reports
• CARBOMEDICS STANDARD M7-021

  HEART-VALVE, MECHANICAL
  2 reports

Recent CARBOMEDICS STANDARD adverse event reports

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

• InjuryDec 4, 2025Break; Break

  THE MANUFACTURER WAS NOTIFIED OF THE INTRAOPERATIVE EXPLANT OF A CARBOMEDICS STANDARD AORTIC VALVE, SIZE 25. THE PROCEDURE WAS AN ISOLATED AORTIC VALVE REPLACEMENT THROUGH FULL STERNOTOMY WITH NO CONCOMITANT PROCEDURES. REPORTEDLY, DURING THE IMPLANTATION OF THE VALVE, ONE OF THE LEAFLETS FRACTURED WHILE THE DEVICE WAS BEING POSITIONED WITHIN THE ANNULUS. BASED ON THE INFORMATION RECEIVED, NO ANOMALOUS MANIPULATION OF THE DEVICE HAS BEEN PERFORMED. THE VALVE WAS THEREFORE EXPLANTED AND ANOTHER CARBOMEDICS STANDARD AORTIC VALVE IN SIZE 25 WAS SUCCESSFULLY IMPLANTED. THE EVENT ADDED 20 MIN IN CROSS-CLAMP TIME AND 20 MIN IN BYPASS TIME. BASED ON THE INFORMATION RECEIVED, THE PATIENT REMAINED STABLE DURING THE DELAY IN SURGERY. THE EVENT WAS INITIALLY DESCRIBED AS A ¿BROKEN CAP¿. HOWEVER, AFTER THE VALVE WAS RECEIVED ON (B)(6) 2025, AND EXAMINED, IT WAS NOTED THAT THE DEVICE HAD A BROKEN LEAFLET AND A BLOOD-STAINED CUFF AND THE EVENT WAS REASSESSED AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23713651 ↗
• InjuryJul 17, 2025Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER WAS INFORMED THAT A DOUBLE VALVE PROCEDURE WITH STANDARD AORTIC AND STANDARD MITRAL WAS PERFORMED ON (B)(6) 2025. AS REPORTED, ALL LOOKED GOOD IN OR. ABOUT 10 DAYS POST-OP PATIENT HAD EFFUSION/HF AND ECHO SHOWED A JAMMED LEAFLET ON MITRAL VALVE. AS SUCH, PATIENT WAS TAKEN BACK TO OR AND SAW SOME MINIMAL PANNUS/TISSUE SURROUNDING THE OCCLUDED LEAFLET. THE PANNUS/TISSUE WAS CLEANED OUT AND USED A RUBBER POKER AND FREED THE LEAFLET. THERE WAS NO SUB-VALVULAR TISSUE. THE VALVE WAS ROTATED 30 DEGREES AND BOTH LEAFLETS FUNCTIONED WELL, AND ECHO WAS FINE IN CVICU. ABOUT 7 DAYS LATER PATIENT HAD EFFUSION/HF AND ECHO SHOWED ONE LEAFLET JAMMED IN OPEN POSITION AND ONE LEAFLET WITH LIMITED MOVEMENT. PATIENT WAS TAKEN BACK TO OR ON (B)(6) AND THE CARBOMEDICS MITRAL 27MM WAS EXPLANTED AND REPLACED WITH A CARBOMEDICS MITRAL SIZE 25MM. REPORTEDLY, PROCEDURE WENT WELL WITH MITRAL VALVE FUNCTIONING PROPERLY, PATIENT IS IN ICU DOING WELL.

  Patient problems: Heart Failure/Congestive Heart Failure; Pericardial Effusion

  MAUDE report 22536500 ↗
• MalfunctionDec 29, 2023Fracture; Fracture

  THE MANUFACTURER WAS INFORMED OF AN INTRA-OPERATIVE EXPLANT OF A CARBOMEDICS STANDARD PROSTHETIC AORTIC HEART VALVE SIZE 21. REPORTEDLY, THE VALVE WAS FRACTURED DURING THE IMPLANT PHASE OF THE SURGERY. ANOTHER AORTIC VALVE OF THE SAME BRAND BUT SMALLER SIZE (A5-019) WAS IMPLANTED INSTEAD, AND THE OPERATION WAS COMPLETED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 18422240 ↗
• MalfunctionSep 29, 2023Fracture; Fracture

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2023 A LEAFLET BREAKAGE WAS EXPERIENCED WHILE IMPLANTING A SIZE 21 CARBOMEDICS STANDARD AORTIC MECHANICAL VALVE. REPORTEDLY, THE PATIENT WAS NOT AFFECTED IN CONSEQUENCE OF THE EVENT. THE MANUFACTURER IS FOLLOWING UP WITH THE SITE TO RETRIEVE ADDITIONAL INFORMATION ON THE EVENT AND THE DEVICE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17842170 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH DEVICE TRACKING DATABASE. IN THE PATIENT REGISTRATION FORM, IT WAS INDICATED THAT A CARBOMEDICS STANDARD PROSTHETIC AORTIC HEART VALVE, A5-016 WAS ''DISPOSED'' ON 18 AUG 2020. BASED ON THE OPERATIONAL REPORT RECEIVED, AFTER SEVERAL ATTEMPTS TO REPAIR THE LEFT AV VALVE, IT WAS DECIDED THAT THE ORIFICE WAS ALWAYS GOING TO BE TOO SMALL, AND BECAUSE THERE WAS AN EXTENSION OF THE VALVULAR TISSUE WHERE THE COMMISSURE BETWEEN THE SUPERIOR BRIDGING LEAFLET AND MURAL LEAFLET SHOULD HAVE BEEN, IT WAS ELECTED TO REPLACE THE VALVE ON THE LEFT SIDE BECAUSE IT FELT THIS WOULD BE THE ONLY WAY TO ACHIEVE AN ADEQUATE INFLOW, WHICH WOULD REMAIN COMPETENT. THE VALVE WAS EXCISED, AND THEY WERE ABLE TO IMPLANT A 16 MM CARBOMEDICS AORTIC PROSTHESIS IN INVERTED POSITION USING 5-0 PROLENE INTERRUPTED MATTRESS SUTURES. THE VALVE APPEARED TO BE SEATED VERY NICELY, AND BOTH LEAFLETS MOVED FREELY. THE HEART WAS ATTEMPTED TO WEAN FROM BYPASS. THE HEART WAS POOR OFF BYPASS WITH MAINTAINED FUNCTION, BUT POOR CARDIAC OUTPUT. A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS OBTAINED. DURING REWARMING, THE VALVE WAS SEEN TO BE OPENING AND CLOSING IN A SYMMETRICAL FA

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 16616503 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH DEVICE TRACKING DATABASE. IN THE PATIENT REGISTRATION FORM, IT WAS INDICATED THAT A CARBOMEDICS STANDARD PROSTHETIC AORTIC HEART VALVE, A5-016 WAS ''DISPOSED'' ON (B)(6) 2020. BASED ON THE OPERATIONAL REPORT RECEIVED, AFTER SEVERAL ATTEMPTS TO REPAIR THE LEFT AV VALVE, IT WAS DECIDED THAT THE ORIFICE WAS ALWAYS GOING TO BE TOO SMALL, AND BECAUSE THERE WAS AN EXTENSION OF THE VALVULAR TISSUE WHERE THE COMMISSURE BETWEEN THE SUPERIOR BRIDGING LEAFLET AND MURAL LEAFLET SHOULD HAVE BEEN, IT WAS ELECTED TO REPLACE THE VALVE ON THE LEFT SIDE BECAUSE IT FELT THIS WOULD BE THE ONLY WAY TO ACHIEVE AN ADEQUATE INFLOW, WHICH WOULD REMAIN COMPETENT. THE VALVE WAS EXCISED, AND THEY WERE ABLE TO IMPLANT A 16 MM CARBOMEDICS AORTIC PROSTHESIS IN INVERTED POSITION USING 5-0 PROLENE INTERRUPTED MATTRESS SUTURES. THE VALVE APPEARED TO BE SEATED VERY NICELY, AND BOTH LEAFLETS MOVED FREELY. THE HEART WAS ATTEMPTED TO WEAN FROM BYPASS. THE HEART WAS POOR OFF BYPASS WITH MAINTAINED FUNCTION, BUT POOR CARDIAC OUTPUT. A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS OBTAINED. DURING REWARMING, THE VALVE WAS SEEN TO BE OPENING AND CLOSING IN A SYMMETRICAL FA

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 16616386 ↗
• InjuryMar 16, 2023Fracture; Fracture

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT. AS REPORTED, ON 13 FEB 2023, CARBOMEDICS STANDARD AORTIC HEART VALVE SIZE 21, A5-021 WAS BROKEN DURING THE OPERATION WHILE PLACING IT TO THE RIGHT ANATOMICAL POSITION. REPORTEDLY, THERE WAS NO ISSUE WITH THE LEAFLETS AND THERE WAS NO NEGATIVE OUTCOME ON THE PATIENT. REPORTEDLY, THERE WAS NO EFFECT ON THE PATIENT AND PATIENT WAS STABLE THROUGH THE DELAY IN THE SURGERY. BASED ON THE INFORMATION RECEIVED, NO DEVICE FAILURE HAS BEEN RECORDED PRIOR TO THIS EVENT, LEAFLETS AND WERE OKAY. REPORTEDLY, IT HAS COME OFF THE HINGE. IN ORDER TO PREVENT LEAKAGE INTO THE VENTRICLE, ONE OF THE LEAFLETS WAS BROKEN WHILE IT WAS BEING REMOVED BY GRASPING THE LEAFLETS. THE MAIN PROBLEM WAS IN THE HINGE SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16559736 ↗
• InjuryOct 20, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2022, DURING THE IMPLANTING PROCEDURE OF A CARBOMEDICS STANDARD AORTIC MECHANICAL HEART VALVE, A5-019, THE DAMAGE OF THE VALVE SEWING RINGS ¿ SLIT WAS NOTED WHICH RESULTED IN FAILURE OF THE SUTURES OF THE VALVE AND WHICH THREATENED THE LIFE OF THE PATIENT. THEREAFTER, A NEW VALVE WAS IMPLANTED IN THE PATIENT. BASED ON THE MEDICAL JUDGEMENT RECEIVED, AT THE BEGINNING OF THE OPERATION, NO UNUSUAL THING WAS NOTICED WITH THE VALVE. THE PROBLEM WAS NOTED DURING THE PROCEDURE, WHEN THE STITCHES WERE PLACED IN THE SEWING RING, SO TEARS ARE CAUSED DURING THE PASSAGE OF THE STITCHES THROUGH THE SEWING RING. THEN, IT WAS DECIDED TO USE ANOTHER VALVE AND PROCEDURE WAS PERFORMED SUCCESSFULLY AND THE PATIENT WAS RELEASED FROM THE HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 15642901 ↗
• InjuryJul 26, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED, A CARBOMEDICS MECHANICAL STANDARD HEART VALVE M7-029 WAS IMPLANTED IN THE PATIENT ON (B)(6) 2022. BASED ON THE INFORMATION ON PATIENT'S IMPLANT FORM, ON (B)(6) 2022, A SIMILAR DEVICE M7-029 WAS IMPLANTED IN THE PATIENT. THE MANUFACTURER HAS NOT RECEIVED ANY ALLEGATION OF DEVICE MALFUNCTION NOR OF SERIOUS INJURY ON THE PATIENT FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 15106052 ↗
• InjuryJul 26, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED, A CARBOMEDICS MECHANICAL STANDARD HEART VALVE M7-029 WAS IMPLANTED IN THE PATIENT ON (B)(6) 2022. BASED ON THE INFORMATION ON PATIENT'S IMPLANT FORM, ON (B)(6) 2022, A SIMILAR DEVICE M7-029 WAS IMPLANTED IN THE PATIENT. THE MANUFACTURER HAS NOT RECEIVED ANY ALLEGATION OF DEVICE MALFUNCTION NOR OF SERIOUS INJURY ON THE PATIENT FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 15106046 ↗
• InjuryJun 17, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION ON THE PATIENT IMPLANT FORM, ON (B)(6) 2022, A CARBOMEDICS STANDARD PROSTHETIC MITRAL HEART VALVE, M7-031 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY AND M7-029 WAS IMPLANTED INSTEAD. NO ALLEGATION OF DEVICE MALFUNCTION NOR SERIOUS INJURY ON THE PATIENT REGARDING THIS EVENT HAS BEEN RECEIVED FROM THE SITE.

  Patient problems: Insufficient Information

  MAUDE report 14735801 ↗
• InjuryJun 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH PATIENT TRACKING DATABASE. BASED ON THE INFORMATION RECEIVED FROM THE PATIENT'S IMPLANT FORM, ON 14 FEBRUARY 2022, A CARBOMEDICS STANDARD PROSTHETIC MITRAL HEART VALVE, M7-025 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY AND ANOTHER M7-025 WAS IMPLANTED IN THE PATIENT INSTEAD. THERE IS NO ALLEGATION OF DEVICE MALFUNCTION NOR SERIOUS INJURY ON THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 14691271 ↗
• InjuryJun 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH PATIENT TRACKING DATABASE. BASED ON THE INFORMATION RECEIVED FROM THE PATIENT'S IMPLANT FORM, ON (B)(6) 2022, A CARBOMEDICS STANDARD PROSTHETIC MITRAL HEART VALVE, M7-025 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY AND ANOTHER M7-025 WAS IMPLANTED IN THE PATIENT INSTEAD. THERE IS NO ALLEGATION OF DEVICE MALFUNCTION NOR SERIOUS INJURY ON THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 14691257 ↗
• InjuryJul 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON THE INFORMATION PROVIDED ON (B)(6) 2021 A CARBOMEDICS 31 MM MITRAL VALVE WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12216198 ↗
• InjuryJul 22, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON THE INFORMATION PROVIDED ON (B)(6) 2021 A CARBOMEDICS 31 MM MITRAL VALVE WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12215223 ↗

Other Corcym Srl products

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• CARBOMEDICS REDUCED6 models · 39 reports
• CARBOMEDICS OPTIFORM6 models · 37 reports
• MEMO 3D RECHORD6 models · 36 reports
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