Septal Occluder Devices Recalled for Incorrect Expiration Date Labeling
W L Gore & Associates recalls GORE CARDIOFORM SEPTAL OCCLUDER devices labeled with a 3-year expiration date when the actual shelf life is 2 years. The mislabeling affects 15 units distributed across the United States and internationally.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling error—incorrect expiration date notation—with no reported illnesses or injuries. Minor labeling errors fall under the Moderate severity category per the established rubric.
Plain-English summary
W L Gore & Associates, Inc. is recalling GORE CARDIOFORM SEPTAL OCCLUDER devices (Catalogue Number GSX0030H, 30 mm diameter) due to incorrect expiration date labeling. The recalled devices are labeled with a 3-year expiration date, but the actual shelf life is 2 years.
The recall affects 15 units with serial numbers 22689696 through 23569078. These devices were distributed to healthcare facilities across all U.S. states and to multiple international locations including Australia, Austria, Canada, Switzerland, Germany, Denmark, Spain, France, the United Kingdom, Greece, Ireland, Italy, Mexico, Netherlands, Norway, Portugal, and Saudi Arabia.
Healthcare providers should verify the actual 2-year expiration date of their GORE CARDIOFORM SEPTAL OCCLUDER devices and not rely solely on the labeled expiration date. Devices with the incorrect labeling should be set aside and returned to W L Gore & Associates, Inc. for replacement or further guidance. Patients and healthcare providers with questions should contact the manufacturer directly.
The recalled product
- Product
- REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within the US
- Manufacturer
- W L Gore & Associates, Inc.
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- serial numbers 22689696 through 23569078
Distribution
Part of a larger recall action
This product is one of 9 recalled by W L Gore & Associates, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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