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SJM™ Masters Series HP

ST. JUDE MEDICAL, INC. · Model 23MHPJ-505 · UDI-DI 05414734021135

LWQ Prescription

510(k) clearances

7,067

Adverse events (901 deaths)

Recalls

Facilities

Description

Mitral HP Rotatable Mechanical Heart Valve

Recalls

Date	Firm	Reason
2026-02-01	On-X Life Technologies, Inc.	Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
2020-02-11	MEDTRONIC ATS MEDICAL, INC.	Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. The valve itself was correctly
2019-01-17	CryoLife, Inc.	On-X Valve was mislabeled with the incorrect serial number.
2015-06-12	CryoLife, Inc.	Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring.
2004-02-18	ATS Medical, Inc.	Normally functioning prosthesis may have been placed on the valve holder mechanism in reverse position.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.