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Amplatzer™
AGA MEDICAL CORPORATION · Model Septal Occluder · UDI-DI 00811806010076
MLV
Prescription
0
510(k) clearances
6,942
Adverse events (197 deaths)
15
Recalls
11
Facilities
Description
Septal Occluder
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. A potential failur |
| 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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Get your free API keyRead the docsData 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.