Masters Series™ 21AJ-501Recalls & reported problems

St. Jude Medical, Inc. · Mechanical Heart Valve · Class 3 · Implant

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 05415067043016), received between Feb 20, 2026 and Feb 20, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incomplete Coaptation” (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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Incomplete Coaptation1

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.

MalfunctionFeb 20, 2026Incomplete Coaptation
IT WAS REPORTED THAT ON 27 JAN 2026, A 21MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN FOR A PROCEDURE. THE LEAFLET FUNCTION WAS TESTED WITH A PLASTIC HOSE. DURING THE OPERATION, THE VALVE LEAFLETS WERE STUCK. AN UNKNOWN SIZE MECHANICAL HEART VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE WHILE PATIENT ON BYPASS. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24401860 ↗

Device details

UDI-DI	`05415067043016`
Brand	Masters Series™
Model	21AJ-501
Company	St. Jude Medical, Inc.
Product code	LWQ · HEART-VALVE, MECHANICAL
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jan 20, 2025

Device type (GMDN): Aortic bi-leaflet mechanical heart valve prosthesis

An artificial substitute for a natural aortic heart valve intended to be implanted during open heart surgery typically to treat acquired or congenital valvular disease. It consists of two flat, semicircular, pyrolytic carbon-coated or polymer leaflets that pivot about pyrolytic carbon or metal struts attached to the valve housing by hinges; the hinge points intersect the valve lumen resulting in a total of three openings. When pressurized blood hits the valve, the two halves of the circle fold away from the valve ring and allow blood to flow into the three openings before the valve flaps close again.

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All HEART-VALVE, MECHANICAL devices →

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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