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W L Gore & Associates, Inc. Recall 91380

Description: GORE CARDIOFORM Septal Occluder, REF: GSX0030A

W L Gore & Associates, Inc. Recall 91380 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1048-2023
Event ID91380
Event DescriptionGORE CARDIOFORM Septal Occluder, REF: GSX0030A
Product TypeDevices
DistributionUS Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA.
Recall ReasonSeptal 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.
Device Classification20230208
Device Code InfoUDI-DI/Serial Numbers: 00733132631032/25556388, 25556389, 25556390, 25556391, 25556392, 25556393, 25556394, 25556398, 25556399, 25556400, 25556401, 25556402, 25556403, 25556406
Center Classification Date20230201
Recall Initiation Date20221214
Recalling FirmW L Gore & Associates, Inc.
Initial Notification Letter
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