Transcatheter Septal Occluder
FDA product code MLV · Class III (high risk) · Cardiovascular
Approved PMA: P000039
0510(k) clearances
5PMA approvals
15recalls
Implantimplanted device
PMA approvals
- P120021 Amplatzer Pfo Occluder · Abbott Medical · 10/28/2016
- P040040 Amplatzer Muscular VSD Occluder · Abbott Medical · 09/07/2007
- P050006 Gore Helex Septal Occluder · W. L. Gore & Associates, Inc. · 08/11/2006
- P000049 Cardioseal Septal Occlusion System with Qwikload · Nmt Medical, Inc. · 12/05/2001
- P000039 The Amplatzer(R) Septal Occluder (Aso) and the Amplatzer Exchange System · Abbott Medical · 12/05/2001
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1048-2023 Class II | GORE CARDIOFORM Septal Occluder, REF: GSX0030ASeptal Occluders released with incomplete quality test documentation that assesses the release of the device… | W L Gore & Associates, Inc. | 12/14/2022Open, Classified |
| Z-0136-2023 Class II | GORE CARDIOFORM ASD Occluder. cardiovascular implant.Due to manufacturing records (Release Test Results) indicating "Failed". | W L Gore & Associates, Inc. | 09/21/2022Open, Classified |
| Z-0172-2022 Class II | REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter…Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date… | W L Gore & Associates, Inc. | 09/02/2021Open, Classified |
| Z-0171-2022 Class II | REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter…Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date… | W L Gore & Associates, Inc. | 09/02/2021Open, Classified |
| Z-0170-2022 Class II | REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter…Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date… | W L Gore & Associates, Inc. | 09/02/2021Open, Classified |
| Z-0169-2022 Class II | REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter…Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date… | W L Gore & Associates, Inc. | 09/02/2021Open, Classified |
| Z-0168-2022 Class II | REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter…Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date… | W L Gore & Associates, Inc. | 09/02/2021Open, Classified |
| Z-0167-2022 Class II | REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter…Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date… | W L Gore & Associates, Inc. | 09/02/2021Open, Classified |
| Z-0166-2022 Class II | REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter…Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date… | W L Gore & Associates, Inc. | 09/02/2021Open, Classified |
| Z-0165-2022 Class II | REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter…Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date… | W L Gore & Associates, Inc. | 09/02/2021Open, Classified |
| Z-0164-2022 Class II | REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter…Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date… | W L Gore & Associates, Inc. | 09/02/2021Open, Classified |
| Z-2234-2015 Class II | Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | EXP Pharmaceutical Services Corp | 02/11/2015Terminated |
| Z-2233-2015 Class II | Medical Device Exchange 10MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | EXP Pharmaceutical Services Corp | 02/11/2015Terminated |
| Z-0053-2007 | AMPLATZER PFO Occluder. Order No. 9-PFO-025. Device is not PMA approved in the US. 25mm…AMPLATZER PFO Occluders were mislabeled with incorrect device sizes. The lot M06B01-58 contains 18mm PFO… | AGA Medical Corporation | 06/01/2006Terminated |
| Z-0052-2007 | AMPLATZER PFO Occluder. Order No. 9-PFO-018. Device is not PMA approved in the US. 18mm…AMPLATZER PFO Occluders were mislabeled with incorrect device sizes. The lot M06B01-58 contains 18mm PFO… | AGA Medical Corporation | 06/01/2006Terminated |