GORE CARDIOFORM Septal Occluder Adverse Events: FDA MAUDE Data
W. L. Gore & Associates, Inc. · Transcatheter Septal Occluder (ASD/PFO) · First cleared Apr 2015 · 4 device variants grouped
Total Reports
277
Reports (30d)
2
Active Signals
0
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
13
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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
Atrial septal defect and patent foramen ovale closure- complication profile of approved Gore Occluders.
Piotrowski M, et al. · Cardiovascular revascularization medicine : including molecular interventions · 2025
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. · Molecular and cellular pediatrics · 2017
Atrial fibrillation after closure of patent foramen ovale in the REDUCE clinical study
Asger Andersen, et al. · Catheterization and Cardiovascular Interventions · 2021
Transcatheter Closure of Atrial Septal Defect: A Review of Currently Used Devices.
Shrivastava S, et al. · Cureus · 2023
Citations indexed from PubMed.
Keep exploring
Related devices in Structural
MitraClip
ABBOTT VASCULAR INC. · 18,874 reports
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
Edwards Lifesciences LLC · 13,813 reports
Evolut FX
MEDTRONIC, INC. · 13,556 reports
Evolut PRO
MEDTRONIC, INC. · 7,814 reports
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC
Edwards Lifesciences LLC · 6,219 reports
WATCHMAN
BOSTON SCIENTIFIC CORPORATION · 4,722 reports
Want automated safety signal detection?
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.
Get Early AccessUnderstanding this data