Home › Device types › MLV
Transcatheter Septal Occluder
FDA product code MLV · Class 3 · Unknown
91
Registered devices
6,878
Adverse events
15
Recalls
0
510(k) clearances
Devices with this code
Amplatzer™ — AGA MEDICAL CORPORATIONAmplatzer™ — ST. JUDE MEDICAL, INC.Amplatzer™ — ST. JUDE MEDICAL, INC.Amplatzer™ — AGA MEDICAL CORPORATIONAMPLATZER™ — AGA MEDICAL CORPORATIONAmplatzer™ — AGA MEDICAL CORPORATIONAmplatzer™ — ST. JUDE MEDICAL, INC.Amplatzer™ — AGA MEDICAL CORPORATIONAmplatzer™ — AGA MEDICAL CORPORATIONAMPLATZER™ — AGA MEDICAL CORPORATIONGORE HELEX Septal Occluder — W. L. Gore & Associates, Inc.AMPLATZER™ — AGA MEDICAL CORPORATIONAmplatzer™ — AGA MEDICAL CORPORATIONAmplatzer™ — AGA MEDICAL CORPORATIONAmplatzer™ — AGA MEDICAL CORPORATIONGORE CARDIOFORM ASD Occluder — W. L. Gore & Associates, Inc.AMPLATZER™ — AGA MEDICAL CORPORATIONAmplatzer™ — AGA MEDICAL CORPORATIONAmplatzer™ Talisman™ — ST. JUDE MEDICAL, INC.Amplatzer™ — ST. JUDE MEDICAL, INC.Amplatzer™ — AGA MEDICAL CORPORATIONAmplatzer™ — ST. JUDE MEDICAL, INC.Amplatzer™ — AGA MEDICAL CORPORATIONAmplatzer™ — AGA MEDICAL CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-12-14 | W L Gore & Associates, Inc. | Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure |
| 2022-09-21 | W L Gore & Associates, Inc. | Due to manufacturing records (Release Test Results) indicating "Failed". |
| 2021-09-02 | W L Gore & Associates, Inc. | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. |
| 2021-09-02 | W L Gore & Associates, Inc. | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. |
| 2021-09-02 | W L Gore & Associates, Inc. | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. |
| 2021-09-02 | W L Gore & Associates, Inc. | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. |
| 2021-09-02 | W L Gore & Associates, Inc. | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. |
| 2021-09-02 | W L Gore & Associates, Inc. | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. |
| 2021-09-02 | W L Gore & Associates, Inc. | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. |
| 2021-09-02 | W L Gore & Associates, Inc. | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. |
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