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Heart-Valve, Mechanical
FDA product code LWQ · Class 3 · Unknown
496
Registered devices
7,067
Adverse events
5
Recalls
0
510(k) clearances
Devices with this code
Open Pivot™ — MEDTRONIC, INC.CARBOMEDICS CARBO-SEAL — CORCYM SRLSJM™ Masters Series — ST. JUDE MEDICAL, INC.Open Pivot™ — MEDTRONIC, INC.Open Pivot™ — MEDTRONIC, INC.Open Pivot™ — MEDTRONIC, INC.Open Pivot™ — MEDTRONIC, INC.Masters Series™ — ST. JUDE MEDICAL, INC.Open Pivot™ — MEDTRONIC, INC.CARBOMEDICS STANDARD — CORCYM SRLOpen Pivot™ — MEDTRONIC, INC.Open Pivot™ — MEDTRONIC, INC.Open Pivot™ — MEDTRONIC, INC.SJM Regent™ — ST. JUDE MEDICAL, INC.SJM™ Masters Series HP — ST. JUDE MEDICAL, INC.Masters Series™ — ST. JUDE MEDICAL, INC.SJM™ Mechanical Heart Valve — ST. JUDE MEDICAL, INC.SJM™ Masters Series HP — ST. JUDE MEDICAL, INC.Open Pivot™ — MEDTRONIC, INC.Open Pivot™ — MEDTRONIC, INC.CARBOMEDICS CARBO-SEAL VALSALVA — CORCYM SRLOpen Pivot™ — MEDTRONIC, INC.Open Pivot™ — MEDTRONIC, INC.Open Pivot™ — MEDTRONIC, INC.
Recent 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 |
| 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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