Transcatheter septal occluder
FDA product code MLV · Class 3 · 80 devices · 3,184 reports · 33 deaths reported · 3 devices named in recalls
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder294 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder1 death213 reports
- GORE CARDIOFORM Septal Occluder GSX0030AW. L. Gore & Associates, Inc. · Transcatheter Septal Occluder1 recall143 reports
- Amplatzer™ Talisman™ 9-PFO-3025St. Jude Medical, Inc. · Transcatheter septal occluder1 death193 reports
- Amplatzer™ 9-ASD-MF-025St. Jude Medical, Inc. · Transcatheter septal occluder1 death183 reports
- Amplatzer™ PFO OccluderSt. Jude Medical, Inc. · Transcatheter septal occluder1 death153 reports
- Amplatzer™ 9-ASD-MF-030St. Jude Medical, Inc. · Transcatheter septal occluder149 reports
- Amplatzer™ Talisman™ 9-PFO-2518St. Jude Medical, Inc. · Transcatheter septal occluder139 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder1 death122 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder101 reports
- GORE CARDIOFORM Septal Occluder GSX0025AW. L. Gore & Associates, Inc. · Transcatheter Septal Occluder1 death93 reports
- GORE CARDIOFORM ASD Occluder ASD37AW. L. Gore & Associates, Inc. · Transcatheter Septal Occluder1 recall42 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder89 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder82 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder2 deaths79 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder1 death79 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder1 death79 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder2 deaths76 reports
- GORE CARDIOFORM ASD Occluder ASD44AW. L. Gore & Associates, Inc. · Transcatheter Septal Occluder1 recall24 reports
- Amplatzer™ PFO OccluderSt. Jude Medical, Inc. · Transcatheter septal occluder1 death62 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder56 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder1 death55 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder48 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder1 death43 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder31 reports
- Amplatzer™ 9-ASD-MF-035St. Jude Medical, Inc. · Transcatheter septal occluder1 death31 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder1 death29 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder29 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder1 death27 reports
- Amplatzer™ Talisman™ 9-PFO-3525St. Jude Medical, Inc. · Transcatheter septal occluder1 death25 reports
- GORE CARDIOFORM ASD Occluder ASD32AW. L. Gore & Associates, Inc. · Transcatheter Septal Occluder23 reports
- GORE CARDIOFORM ASD Occluder ASD48AW. L. Gore & Associates, Inc. · Transcatheter Septal Occluder23 reports
- Amplatzer™ 9-ASD-022Aga Medical Corporation · Transcatheter septal occluder22 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder2 deaths21 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder18 reports
- Amplatzer™ PFO OccluderSt. Jude Medical, Inc. · Transcatheter septal occluder18 reports
- Amplatzer™ 9-ASD-030Aga Medical Corporation · Transcatheter septal occluder1 death17 reports
- Amplatzer™ 9-ASD-016Aga Medical Corporation · Transcatheter septal occluder16 reports
- AMPLATZER™ 9-ASD-008Aga Medical Corporation · Transcatheter septal occluder15 reports
- Amplatzer™ 9-VSD-MUSC-016St. Jude Medical, Inc. · Transcatheter septal occluder2 deaths14 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder13 reports
- Amplatzer™ 9-ASD-020Aga Medical Corporation · Transcatheter septal occluder13 reports
- Amplatzer™ 9-ASD-028Aga Medical Corporation · Transcatheter septal occluder13 reports
- Amplatzer™ Post Infarct Muscular VSD OccluderAga Medical Corporation · Transcatheter Septal Occluder4 deaths13 reports
- Amplatzer™ 9-VSD-MUSC-012St. Jude Medical, Inc. · Transcatheter septal occluder11 reports
- AMPLATZER™ 9-ASD-009Aga Medical Corporation · Transcatheter septal occluder11 reports
- Amplatzer™ Talisman™ 9-PFO-1818St. Jude Medical, Inc. · Transcatheter septal occluder11 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder10 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder10 reports
- Amplatzer™ 9-VSD-MUSC-008St. Jude Medical, Inc. · Transcatheter septal occluder1 death10 reports
- Amplatzer™ 9-VSD-MUSC-010St. Jude Medical, Inc. · Transcatheter septal occluder10 reports
- Amplatzer™ 9-VSD-MUSC-014St. Jude Medical, Inc. · Transcatheter septal occluder1 death10 reports
- Amplatzer™ 9-VSD-MUSC-018St. Jude Medical, Inc. · Transcatheter septal occluder10 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder8 reports
- Amplatzer™ 9-VSD-MUSC-006St. Jude Medical, Inc. · Transcatheter septal occluder1 death7 reports
- Amplatzer™ 9-ASD-MF-018St. Jude Medical, Inc. · Transcatheter septal occluder6 reports
- Amplatzer™ 9-ASD-017Aga Medical Corporation · Transcatheter septal occluder5 reports
- Amplatzer™ 9-ASD-036Aga Medical Corporation · Transcatheter septal occluder5 reports
- Amplatzer™ 9-ASD-038Aga Medical Corporation · Transcatheter septal occluder5 reports
- GORE CARDIOFORM Septal Occluder GSX0020AW. L. Gore & Associates, Inc. · Transcatheter Septal Occluder4 reports
- Amplatzer™ 9-ASD-013Aga Medical Corporation · Transcatheter septal occluder4 reports
- Amplatzer™ 9-ASD-026Aga Medical Corporation · Transcatheter septal occluder1 death4 reports
- GORE HELEX Septal Occluder HX2025W. L. Gore & Associates, Inc. · Transcatheter Septal Occluder3 reports
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder3 reports
- AMPLATZER™ 9-ASD-012Aga Medical Corporation · Transcatheter septal occluder3 reports
- Amplatzer™ 9-ASD-024Aga Medical Corporation · Transcatheter septal occluder3 reports
- Amplatzer™ Post Infarct Muscular VSD OccluderAga Medical Corporation · Transcatheter Septal Occluder1 death3 reports
- GORE HELEX Septal Occluder HX2030W. L. Gore & Associates, Inc. · Transcatheter Septal Occluder2 reports
- GORE CARDIOFORM ASD Occluder ASD27AW. L. Gore & Associates, Inc. · Transcatheter Septal Occluder2 reports
- Amplatzer™ 9-VSD-MUSC-004St. Jude Medical, Inc. · Transcatheter septal occluder2 reports
- AMPLATZER™ 9-ASD-005Aga Medical Corporation · Transcatheter septal occluder2 reports
- Amplatzer™ 9-ASD-034Aga Medical Corporation · Transcatheter septal occluder2 reports
- Amplatzer™ Post Infarct Muscular VSD OccluderAga Medical Corporation · Transcatheter Septal Occluder2 reports
- Amplatzer™ Post Infarct Muscular VSD OccluderAga Medical Corporation · Transcatheter Septal Occluder2 reports
- GORE HELEX Septal Occluder HX2035W. L. Gore & Associates, Inc. · Transcatheter Septal Occluder1 report
- Amplatzer™ Septal OccluderAga Medical Corporation · Transcatheter septal occluder1 report
- AMPLATZER™ 9-ASD-010Aga Medical Corporation · Transcatheter septal occluder1 report
- Amplatzer™ 9-ASD-014Aga Medical Corporation · Transcatheter septal occluder1 report
- Amplatzer™ 9-ASD-018Aga Medical Corporation · Transcatheter septal occluder1 report
- Amplatzer™ Post Infarct Muscular VSD OccluderAga Medical Corporation · Transcatheter Septal Occluder1 report