GORE CARDIOFORM ASD Occluder Adverse Events: FDA MAUDE Data
W. L. Gore & Associates, Inc. · Transcatheter Septal Occluder (ASD/PFO) · First cleared May 2019 · 5 device variants grouped
Total Reports
275
Reports (30d)
9
Active Signals
1
Open Recalls
11
What the reports describe · Claripulse analysis
Most commonly reported problems
Pericardial Effusion During Deployment
implanted gore, disc thickness, asd occluder, cardioform asd, physician implanted
12
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
Dec 14, 2022 · Open, Classified
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 failure of this quality test could potentially result could result in occluder embolization, anoxic brain injury, central venous or arterial perforation or rupture.
Sep 21, 2022 · Open, Classified
Due to manufacturing records (Release Test Results) indicating "Failed".
Sep 2, 2021 · Open, Classified
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Sep 2, 2021 · Open, Classified
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Sep 2, 2021 · Open, Classified
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Sep 2, 2021 · Open, Classified
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Evidence
Related research
Mullins-Sheath Facilitated Delivery of Gore Cardioform ASD Occluder Devices for Closure of Large or Challenging Secundum Atrial Septal Defects.
Eilers LF, et al. · The Journal of invasive cardiology · 2021
Right disc thrombosis of the new Gore Cardioform ASD Occluder.
Oliva OA, et al. · Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2024
Long-Term Results of the Atrial Septal Defect Occluder ASSURED Trial for Combined Pivotal/Continued Access Cohorts.
Qureshi AM, et al. · JACC. Cardiovascular interventions · 2024
A novel device for atrial septal defect occlusion (GORE CARDIOFORM).
Hribernik I, et al. · EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023
ASD Occluder Used to Close a Mustard Baffle Leak.
Schreier M, et al. · JACC. Case reports · 2026
Citations indexed from PubMed.
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