CARBOMEDICS CARBO-SEAL VALSALVA CP-021Recalls & 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
- 2
- Deaths reported
- 2
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08022057013538), received between Dec 23, 2020 and Dec 23, 2020 — classified as 2 deaths.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information2
Patient problems
- Death2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗
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.
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