GORE Cardioform Septal Occluder recalled for incorrect expiration date labeling
W.L. Gore is recalling 138 units of GORE Cardioform Septal Occluder devices labeled with a 3-year expiration date instead of the actual 2-year shelf life.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a labeling error on a Class II cardiac intervention device where the label indicates a longer shelf life (3 years) than the actual shelf life (2 years). Using devices beyond their actual shelf life creates a risk of device degradation and failure during cardiac procedures. No illnesses or injuries have been reported.
Plain-English summary
W.L. Gore & Associates, Inc. is recalling the GORE Cardioform Septal Occluder (20 mm diameter, Catalogue Number GSX0020A) due to a labeling error. The affected devices are labeled with a 3-year expiration date, but the actual shelf life is 2 years.
The incorrect expiration date could lead clinicians or healthcare facilities to use devices beyond their actual usable shelf life, potentially resulting in device degradation and performance failure during cardiac interventions. A total of 138 units were distributed with serial numbers from 22689696 through 23569078.
Affected devices were distributed nationwide in the United States and to Australia, Austria, Canada, Switzerland, Germany, Denmark, Spain, France, United Kingdom, Greece, Ireland, Italy, Mexico, Netherlands, Norway, Portugal, Saudi Arabia, and Sweden. Clinicians and healthcare facilities should verify the actual 2-year expiration date and not use affected devices beyond that timeframe. W.L. Gore & Associates is contacting affected customers directly.
The recalled product
- Product
- REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631018
- Manufacturer
- W L Gore & Associates, Inc.
- Hazard
- Affected units
- 138
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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