CARBOMEDICS CARBO-SEAL VALSALVA CP-025Recalls & reported problems
Corcym Srl · Class 3 · Implant
All models of CARBOMEDICS CARBO-SEAL VALSALVA (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 1
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08022057013552), received between Mar 29, 2018 and Feb 14, 2023 — classified as 1 death, 6 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
Device problems
- Insufficient Device Problem Information7
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information4
- No Information2
- Death1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗InjuryOct 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2019 A PATIENT RECEIVED A CARBOSEAL VALSALVA CP-025 AS PART OF AN AORTIC VALVE REPLACEMENT OF A DIFFERENT VALVE IMPLANT. THE DEVICE WAS EXPLANTED AFTER 10 DAYS ON (B)(6) 2019 USING THE BENTALL PROCEDURE. AS OF NOW, IT IS UNKNOWN WHAT DEVICE HAD BEEN ALREADY IMPLANTED AND WHY THE CARBOSEAL WAS EXPLANTED.
Patient problems: No Information
MAUDE report 9263724 ↗InjuryOct 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2019 A PATIENT RECEIVED A CARBOSEAL VALSALVA CP-025 AS PART OF AN AORTIC VALVE REPLACEMENT OF A DIFFERENT VALVE IMPLANT. THE DEVICE WAS EXPLANTED AFTER 10 DAYS ON (B)(6) 2019 USING THE BENTALL PROCEDURE. AS OF NOW, IT IS UNKNOWN WHAT DEVICE HAD BEEN ALREADY IMPLANTED AND WHY THE CARBOSEAL WAS EXPLANTED.
Patient problems: No Information
MAUDE report 9263668 ↗DeathMar 29, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
A CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS WAS IMPLANTED ON (B)(6) 2017. THE PATIENT PASSED AWAY ON (B)(6) 2018.
Patient problems: Death
MAUDE report 7382391 ↗
Other HEART-VALVE, MECHANICAL devices
- On-X Mitral Heart Valve with Conform-X Sewing Ring ONXMC-25/33On-X Life Technologies, Inc. · Heart-Valve, Mechanical1 recall1 death34 reports
- SJM Regent™ AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL3 deaths70 reports
- SJM Regent™ AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL5 deaths66 reports
- SJM Regent™ 23AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL3 deaths44 reports
- CARBOMEDICS SUPRA-ANNULAR (TOP HAT) S5-021Corcym Srl · HEART-VALVE, MECHANICAL7 deaths37 reports
- Regent™ 21AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL3 deaths35 reports
- Regent™ 23AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL2 deaths33 reports
- Regent™ 19AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL31 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page