CARBOMEDICS CARBO-SEAL VALSALVARecalls & reported problems across all models
Corcym Srl · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 24
- Deaths reported
- 6
- Injuries reported
- 17
- Recalls
- 0
We found 5 models of CARBOMEDICS CARBO-SEAL VALSALVA by Corcym Srl in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Sep 7, 2016 and Dec 28, 2023 — classified as 6 deaths, 17 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (21 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
Reports received per month, all models
Most reported CARBOMEDICS CARBO-SEAL VALSALVA problems
Device problems
- Insufficient Device Problem Information21
- Adverse Event Without Identified Device or Use Problem4
- Detachment of Device or Device Component2
- Activation, Positioning or Separation Problem1
- Defective Component1
- Delivery System Failure1
- Device Markings/Labelling Problem1
- Leak/Splash1
Patient problems
- Insufficient Information8
- No Information6
- Cardiac Arrest4
- Death3
- Bacterial Infection2
- Cardiogenic Shock2
- Chest Pain2
- Hemorrhage/Blood Loss/Bleeding2
CARBOMEDICS CARBO-SEAL VALSALVA models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CARBOMEDICS CARBO-SEAL VALSALVA CP-025HEART-VALVE, MECHANICAL1 death7 reports
- CARBOMEDICS CARBO-SEAL VALSALVA CP-023HEART-VALVE, MECHANICAL1 death6 reports
- CARBOMEDICS CARBO-SEAL VALSALVA CP-029HEART-VALVE, MECHANICAL2 deaths5 reports
- CARBOMEDICS CARBO-SEAL VALSALVA CP-027HEART-VALVE, MECHANICAL4 reports
- CARBOMEDICS CARBO-SEAL VALSALVA CP-021HEART-VALVE, MECHANICAL2 deaths2 reports
Recent CARBOMEDICS CARBO-SEAL VALSALVA adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH DEVICE TRACKING DEPARTMENT. REPORTEDLY, ON (B)(6) 2012, A CARBOSEAL VALSALVA VALVE CP-029 WAS IMPLANTED IN A PATIENT. THE DEVICE WAS EXPLANTED AND REPLACED WITH A PERCEVAL VALVE PVS27 ON (B)(6)2017. NO ALLEGATION OF ANY DEVICE DYSFUNCTION OR SERIOUS INJURY ON THE PATIENT HAS YET BEEN REPORTED FROM THE SITE.
Patient problems: Insufficient Information
MAUDE report 18416333 ↗InjuryDec 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH DEVICE TRACKING DEPARTMENT. REPORTEDLY, ON 14 JAN 2012, A CARBOSEAL VALSALVA VALVE CP-029 WAS IMPLANTED IN A PATIENT. THE DEVICE WAS EXPLANTED AND REPLACED WITH A PERCEVAL VALVE PVS27 ON (B)(6) 2017. NO ALLEGATION OF ANY DEVICE DYSFUNCTION OR SERIOUS INJURY ON THE PATIENT HAS YET BEEN REPORTED FROM THE SITE.
Patient problems: Insufficient Information
MAUDE report 18414630 ↗InjuryFeb 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER RECEIVED THE FOLLOWING INFORMATION THROUGH PATIENT TRACKING DEPARTMENT. A CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS CP-025 WHICH WAS IMPLANTED ON (B)(6) 2019, WAS EXPLANTED ON (B)(6) 2022. NO INFORMATION HAS BEEN RECEIVED FROM THE SITE ABOUT ANY ALLEGATION OF DEVICE MALFUNCTION NOR OF SERIOUS PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 16376144 ↗InjuryFeb 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER RECEIVED THE FOLLOWING INFORMATION THROUGH PATIENT TRACKING DEPARTMENT. A CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS CP-025 WHICH WAS IMPLANTED ON (B)(6) 2019, WAS EXPLANTED ON (B)(6) 2022. NO INFORMATION HAS BEEN RECEIVED FROM THE SITE ABOUT ANY ALLEGATION OF DEVICE MALFUNCTION NOR OF SERIOUS PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 16376140 ↗InjuryDec 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER BECAME AWARE OF THE FOLLOWING EVENT THROUGH MANTRA STUDY. ON (B)(6) 2022, CARBOSEAL VALSALVA CONDUIT/VALVE CP-023 WAS IMPLANTED IN AORTIC POSITION THROUGH MEDIAN STERNOTOMY. THE CONCOMITANT PROCEDURE WAS AORTIC ROOT REPLACEMENT (BENTALL PROCEDURE). BASED ON THE X-RAY PERFORMED ON (B)(6) 2022, CARDIAC SIZE REMAINED ENLARGED WITH VALVULAR PROSTHESIS IN PLACE. CHEST TUBE WAS SEEN ON THE RIGHT WITH NO PNEUMOTHORAX. PATCHY BILATERAL AIRSPACE CONSOLIDATION AND SOME PLEURAL FLUID COULD BE SEEN THAT WAS A LITTLE WORSE THAN THE DAY BEFORE. BASED ON THE X-RAY PERFORMED ON (B)(6) 2022, MINOR WORSENING OF BIBASILAR AIRSPACE CONSOLIDATION, WITH APPEARANCE OF THE CHEST OTHERWISE UNCHANGED FROM THE X-RAY PERFORMED ON (B)(6) 2022. REPORTEDLY, CARDIAC ARREST AND HEMORRHAGE STARTED ON (B)(6) 2022. THE OUTCOME WAS INDICATED AS RECOVERED/RESOLVED AFTER PATIENT UNDERWENT A SURGICAL PROCEDURE: BEDSIDE - THORACOTOMY AND THEN IN OPERATING ROOM - MEDIASTINUM EXPLORATION; AND OTHER NON-SURGICAL PROCEDURE: BEDSIDE BRONCHOSCOPY.
Patient problems: Cardiac Arrest; Cardiogenic Shock; Hemorrhage/Blood Loss/Bleeding
MAUDE report 15896615 ↗InjuryDec 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER BECAME AWARE OF THE FOLLOWING EVENT THROUGH MANTRA STUDY. ON (B)(6) 2022, CARBOSEAL VALSALVA CONDUIT/VALVE CP-023 WAS IMPLANTED IN AORTIC POSITION THROUGH MEDIAN STERNOTOMY. THE CONCOMITANT PROCEDURE WAS AORTIC ROOT REPLACEMENT (BENTALL PROCEDURE). BASED ON THE X-RAY PERFORMED ON (B)(6) 2022, CARDIAC SIZE REMAINED ENLARGED WITH VALVULAR PROSTHESIS IN PLACE. CHEST TUBE WAS SEEN ON THE RIGHT WITH NO PNEUMOTHORAX. PATCHY BILATERAL AIRSPACE CONSOLIDATION AND SOME PLEURAL FLUID COULD BE SEEN THAT WAS A LITTLE WORSE THAN THE DAY BEFORE. BASED ON THE X-RAY PERFORMED ON (B)(6) 2022, MINOR WORSENING OF BIBASILAR AIRSPACE CONSOLIDATION, WITH APPEARANCE OF THE CHEST OTHERWISE UNCHANGED FROM THE X-RAY PERFORMED ON (B)(6) 2022. REPORTEDLY, CARDIAC ARREST AND HEMORRHAGE STARTED ON (B)(6) 2022. THE OUTCOME WAS INDICATED AS RECOVERED/RESOLVED AFTER PATIENT UNDERWENT A SURGICAL PROCEDURE: BEDSIDE - THORACOTOMY AND THEN IN OPERATING ROOM - MEDIASTINUM EXPLORATION; AND OTHER NON-SURGICAL PROCEDURE: BEDSIDE BRONCHOSCOPY.
Patient problems: Cardiac Arrest; Cardiogenic Shock; Hemorrhage/Blood Loss/Bleeding
MAUDE report 15896329 ↗InjuryApr 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH PATIENT TRACKING DATABASE. BASED ON THE INFORMATION ON THE PATIENT IMPLANT FORM, THE CARBOSEAL VALSALVA SIZE 25 THAT WAS IMPLANTED IN THE PATIENT ON (B)(6) 2017 HAS BEEN EXPLANTED 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 14016121 ↗InjuryApr 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH PATIENT TRACKING DATABASE. BASED ON THE INFORMATION ON THE PATIENT IMPLANT FORM, THE CARBOSEAL VALSALVA SIZE 25 THAT WAS IMPLANTED IN THE PATIENT ON (B)(6) 2017 HAS BEEN EXPLANTED 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 14015982 ↗InjuryMay 7, 2021Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED OF THE EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A CARBOSEAL VALSALVA CP-029 WAS IMPLANTED ON (B)(6) 2017 AND EXPLANTED ON (B)(6) 2021, TO BE REPLACED BY A SIMILAR DEVICE CP-029. 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. PER ADDITIONAL INFORMATION RECEIVED, IT WAS REPORTED THAT THE PATIENT CLINICAL HISTORY INCLUDES MARFAN SYNDROME (DX AS A CHILD), AORTIC ROOT ANEURISM S/P BENTALL WITH CABROL MODIFICATION, DEBAKEY TYPE III DISSECTION S/P URGENT TEVAR REPAIR ON (B)(6) 2018, OSTEOARTHRITIS, HYPERTENSION, RETINAL DETACHMENT AND GOUT. THE PATIENT WAS ADMITTED ON (B)(6) 2020 WITH C/O CHEST PAIN AND THE HOSPITAL COURSE WAS COMPLICATED BY COVID STATUS, AKI, OXYGEN REQUIREMENT AND SUPRA AND SUB THERAPEUTIC INR. THE PATIENT WAS FOUND TO HAVE MSSA BACTEREMIA. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS AND A DECISION WAS MADE FOR THE PATIENT TO RECOVER FROM COVID SYMPTOMS AND GET A CT SCAN IN 4 WEEKS. THE PATIENT PRESENTED BACK WITH FEVER AND CHILLS AND CHEST PAIN. A REPEATED CAT SC
Patient problems: Bacterial Infection; Chest Pain; Insufficient Information
MAUDE report 11793538 ↗InjuryMay 7, 2021Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED OF THE EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A CARBOSEAL VALSALVA CP-029 WAS IMPLANTED ON (B)(6) 2017 AND EXPLANTED ON (B)(6) 2021, TO BE REPLACED BY A SIMILAR DEVICE CP-029. 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. PER ADDITIONAL INFORMATION RECEIVED, IT WAS REPORTED THAT THE PATIENT CLINICAL HISTORY INCLUDES MARFAN SYNDROME (DX AS A CHILD), AORTIC ROOT ANEURISM S/P BENTALL WITH CABROL MODIFICATION, DEBAKEY TYPE III DISSECTION S/P URGENT TEVAR REPAIR ON (B)(6) 2018, OSTEOARTHRITIS, HYPERTENSION, RETINAL DETACHMENT AND GOUT. THE PATIENT WAS ADMITTED ON (B)(6) 2020 WITH C/O CHEST PAIN AND THE HOSPITAL COURSE WAS COMPLICATED BY COVID STATUS, AKI, OXYGEN REQUIREMENT AND SUPRA AND SUB THERAPEUTIC INR. THE PATIENT WAS FOUND TO HAVE MSSA BACTEREMIA. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS AND A DECISION WAS MADE FOR THE PATIENT TO RECOVER FROM COVID SYMPTOMS AND GET A CT SCAN IN 4 WEEKS. THE PATIENT PRESENTED BACK WITH FEVER AND CHILLS AND CHEST PAIN. A REPEATED CAT SC
Patient problems: Bacterial Infection; Chest Pain; Insufficient Information
MAUDE report 11793434 ↗MalfunctionMar 27, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem
ON (B)(6) 2021, THE MANUFACTURER BECAME AWARE OF A PRODUCT MIS-LABELLING WITH A LIVANOVA DEVICE. IN PARTICULAR, A CARBOSEAL DEVICE MODEL CP-023 WAS IMPLANTED IN A PATIENT. HOWEVER, THE SERIAL NUMBER OF THE DEVICE THAT APPEARS IN THE PATIENT'S REGISTRATION FORM IS NOT THE SAME AS THE SERIAL NUMBER APPEARING ON THE MEDICAL RECORDS OF THE HOSPITAL. FURTHERMORE, THE DEVICE MODEL CP-023 WITH THE SAME SERIAL NUMBER SHOWED ON THE PATIENT'S IMPLANT CARD WAS RETURNED TO THE MANUFACTURER AS EXPIRED AND NOT USED FOR ANY IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11579914 ↗DeathDec 23, 2020Adverse 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) 2020, A PATIENT UNDERWENT A RE-DO AORTIC VALVE REPLACEMENT TO EXPLANT A DEGENERATED MITROFLOW VALVE (REF (B)(4) AND RECEIVED A CARBOSEAL VALSALVA CP-021. A RIGHT COMMON FEMORAL ARTERY BALLOON PUMP AND A RIGHT SWAN-GANZ CATHETER WERE PLACED AT THE TIME OF THE RE-DO PROCEDURE. THE PATIENT WAS MOVED TO THE ICU IN CRITICAL CONDITIONS. THE PATIENT SLOWLY DETERIORATED ON POD1 REQUIRING MORE INOTROPIC SUPPORT AND VENTILATOR SUPPORT. THE PATIENT PASSED AWAY ON (B)(6) 2020.
Patient problems: Death
MAUDE report 11068738 ↗DeathDec 23, 2020Adverse 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) 2020, A PATIENT UNDERWENT A RE-DO AORTIC VALVE REPLACEMENT TO EXPLANT A DEGENERATED MITROFLOW VALVE ((B)(4)) AND RECEIVED A CARBOSEAL VALSALVA CP-021. A RIGHT COMMON FEMORAL ARTERY BALLOON PUMP AND A RIGHT SWAN-GANZ CATHETER WERE PLACED AT THE TIME OF THE RE-DO PROCEDURE. THE PATIENT WAS MOVED TO THE ICU IN CRITICAL CONDITIONS. THE PATIENT SLOWLY DETERIORATED ON POD1 REQUIRING MORE INOTROPIC SUPPORT AND VENTILATOR SUPPORT. THE PATIENT PASSED AWAY ON (B)(6) 2020.
Patient problems: Death
MAUDE report 11068730 ↗DeathNov 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2020, A PATIENT RECEIVED A CARBOSEAL VALSALVA MODEL CP-029 AS PART OF A STANDARD BENTALL PROCEDURE. AORTA ASCENDENS ANEURISME 6,7CM. PARASYSTISK AFIB, PV ISOLATION. THE PROCEDURE WENT WELL, WITH NO COMPLICATIONS REPORTED AND THE PATIENT WAS MOVED TO THE ICU. AN INITIAL UNEVENTFUL POSTOPERATIVE COURSE WAS REPORTED. AFTER 36 HOURS, THE PATIENT WENT INTO CARDIAC ARREST, AND WAS BROUGHT BACK TO THE OPERATING ROOM WHERE AN INTERNAL CARDIAC MASSAGE WAS STARTED, THEN ON BYPASS AND CPS WITHIN 25 MINUTES. ONCE THE HEART WAS STOPPED, UPON EXAMINATION THEY NOTICED A MASSIVE THROMBOSIS IN CENTRAL PART OF PROTHESIS OCCLUDING LEFT MAIN AND LAD CORONARY. THROMBOSIS WAS ABLE TO BE EVACUATED GIVING RETROGRADE PLEGIA SOLUTION THAT PUSHED THE THROMBOSIS OUT. THE LEFT VENTRICLE REPORTEDLY NOT PUMPING EFFICIENTLY (EF 5-10% DUE TO AN INFARCTION OF THE LEFT VENTRICLE). THE PATIENT WAS PUT UNDER ECMO SUPPORT AND TRANSFERRED TO ANOTHER FACILITY (TRANSPLANTATION CENTER) ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT PASSED AWAY (EXACT DAY NOT YET INFORMED).
Patient problems: Cardiac Arrest; Left Ventricular Failure; Thrombosis
MAUDE report 10901685 ↗DeathNov 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2020, A PATIENT RECEIVED A CARBOSEAL VALSALVA MODEL CP-029 AS PART OF A STANDARD BENTALL PROCEDURE. AORTA ASCENDENS ANEURISME 6,7CM. PARASYSTISK AFIB, PV ISOLATION. THE PROCEDURE WENT WELL, WITH NO COMPLICATIONS REPORTED AND THE PATIENT WAS MOVED TO THE ICU. AN INITIAL UNEVENTFUL POSTOPERATIVE COURSE WAS REPORTED. AFTER 36 HOURS, THE PATIENT WENT INTO CARDIAC ARREST, AND WAS BROUGHT BACK TO THE OPERATING ROOM WHERE AN INTERNAL CARDIAC MASSAGE WAS STARTED, THEN ON BYPASS AND CPS WITHIN 25 MINUTES. ONCE THE HEART WAS STOPPED, UPON EXAMINATION THEY NOTICED A MASSIVE THROMBOSIS IN CENTRAL PART OF PROTHESIS OCCLUDING LEFT MAIN AND LAD CORONARY. THROMBOSIS WAS ABLE TO BE EVACUATED GIVING RETROGRADE PLEGIA SOLUTION THAT PUSHED THE THROMBOSIS OUT. THE LEFT VENTRICLE REPORTEDLY NOT PUMPING EFFICIENTLY (EF 5-10% DUE TO AN INFARCTION OF THE LEFT VENTRICLE). THE PATIENT WAS PUT UNDER ECMO SUPPORT AND TRANSFERRED TO ANOTHER FACILITY (TRANSPLANTATION CENTER) ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT PASSED AWAY (EXACT DAY NOT YET INFORMED).
Patient problems: Cardiac Arrest; Left Ventricular Failure; Thrombosis
MAUDE report 10901554 ↗
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 REDUCED6 models · 39 reports
- CARBOMEDICS OPTIFORM6 models · 37 reports
- MEMO 3D RECHORD6 models · 36 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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