Gore CARDIOFORM Septal Occluder recalled for incorrect expiration date
W.L. Gore & Associates is recalling 2,238 GORE CARDIOFORM SEPTAL OCCLUDER 30 mm devices labeled with a 3-year expiration date instead of the actual 2-year expiration date.
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 Class II medical device recall with incorrect expiration dating. While no illnesses or injuries have been reported, the mislabeling creates risk of harm if the cardiac catheterization device is used beyond its actual 2-year shelf life.
Plain-English summary
W.L. Gore & Associates is recalling 2,238 units of the GORE CARDIOFORM SEPTAL OCCLUDER 30 mm (Catalogue Number GSX0030A, Serial Numbers 22689696 through 23569078) due to incorrect expiration date labeling.
The affected devices are labeled with a 3-year expiration date when the actual product expiration date is 2 years. The devices were distributed throughout the United States and internationally to multiple countries including Canada, Mexico, Australia, and several European nations.
Healthcare facilities and clinicians who have received these devices should verify the actual expiration date against the product label. Any devices that may have exceeded the actual 2-year shelf life should be quarantined or discarded per facility protocols. Adverse events or product concerns should be reported to the manufacturer or the FDA.
The recalled product
- Product
- REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032
- Manufacturer
- W L Gore & Associates, Inc.
- Affected units
- 2,238
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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