W. L. Gore & Associates, Inc. · Transcatheter Septal Occluder (ASD/PFO) · First cleared Aug 2006
Total Reports
145
Reports (30d)
2
Active Signals
1
Open Recalls
11
What the reports describe · Claripulse analysis
Device Embolization During Implant
foramen, pfo, gore cardioform, patent, cardioform
5
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
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
Single tertiary center experience using Gore Cardioform Atrial Septal Defect Occluder for secundum atrial septal defect closure with a focus on deficient rims.
Subhrajit Lahiri, et al. · PubMed · 2023
Transcatheter atrial septal defect closure in an infant (body weight 6.4 kg) using the GORE CARDIOFORM septal occluder (GCSO).
Scheidmann R, et al. · 2017
Atrial fibrillation after closure of patent foramen ovale in the <scp>REDUCE</scp> clinical study
Asger Andersen, et al. · Catheterization and Cardiovascular Interventions · 2021
From Mild Discomfort to Myopericarditis—A Complication of Patent Foramen Ovale Occluder Device Placement: A Case Report
Anastasia Proshkina, et al. · Journal of the Society for Cardiovascular Angiography & Interventions · 2025
Citations indexed from PubMed.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
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