CARBOMEDICS STANDARD A5-029Recalls & reported problems
Corcym Srl · Class 3 · Implant
All models of CARBOMEDICS STANDARD (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08022057012654), received between Jun 2, 2020 and Jun 2, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component2
- Insufficient Device Problem Information2
Patient problems
- Endocarditis2
- No Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 2, 2020Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED ABOUT A CARBOMEDICS STANDARD HEART VALVE, MODEL # A5-029, SERIAL # (B)(4) THAT WAS IMPLANTED ON (B)(6) 2018. THE DEVICE WAS EVENTUALLY EXPLANTED AND REPLACED WITH ANOTHER DEVICE CARBOSEAL VALSALVA VALVE CP-027 ON (B)(6) 2019. NO OTHER INFORMATION WAS PROVIDED TO-DATE.
Patient problems: Endocarditis; No Information
MAUDE report 10112320 ↗InjuryJun 2, 2020Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED ABOUT A CARBOMEDICS STANDARD HEART VALVE MODEL # A5-029, SERIAL # (B)(4) THAT WAS IMPLANTED ON (B)(6) 2018. THE DEVICE WAS EVENTUALLY EXPLANTED AND REPLACED WITH ANOTHER DEVICE CARBOSEAL VALSALVA VALVE CP-027 ON (B)(6) 2019. NO OTHER INFORMATION WAS PROVIDED TO-DATE.
Patient problems: Endocarditis; No Information
MAUDE report 10112169 ↗
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