GORE CARDIOFORM ASD Occluder Adverse Events: FDA MAUDE Data
W. L. Gore & Associates, Inc. · Transcatheter Septal Occluder (ASD/PFO) · First cleared Aug 2006
Total Reports
137
Reports (30d)
0
Active Signals
1
Open Recalls
11
What the reports describe · Claripulse analysis
Most commonly reported problems
Device Slippage with Pericardial Effusion
asd occluder, cardioform asd, gore cardioform, cardioform, cardioform septal
7
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.
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