Masters Series™ 27CAVGJ-514 00Recalls & reported problems
St. Jude Medical, Inc. · Aortic Valved Graft with Hemashield Graft technology Mechanical Valved Graft · Class 3 · Implant
All models of Masters Series (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067044112), received between Jul 26, 2024 and Jul 26, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 26, 2024Improper or Incorrect Procedure or Method; Contamination /Decontamination Problem; Improper or Incorrect Procedure or Method; Contamination /Decontamination Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 27MM SJM MASTERS SERIES COATED AORTIC VALVED GRAFT WAS CHOSEN FOR A PROCEDURE. THE VALVE GRAFT APPEARED NORMAL DURING PREPARATION. DURING PROCEDURE, THE SURGEON FOUND LARGE AMOUNT OF YELLOW DOTS INSIDE THE CONDUIT. THE CONDUIT WAS IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS A DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED DISCHARGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19838254 ↗
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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