GORE CARDIOFORM Septal Occluder Labeled with Incorrect Expiration Date
W L Gore & Associates is recalling GORE CARDIOFORM Septal Occluder devices labeled with a 3-year expiration date instead of the correct 2-year date. Mislabeling could result in use of devices beyond their intended safe lifespan.
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 classified as a labeling error on an important safety parameter. While the device itself is not defective and no illnesses or injuries have been reported, incorrect expiration dating could result in use beyond the actual safe lifespan. FDA Class II classification without reported hospitalizations or adverse events corresponds to Moderate severity.
Plain-English summary
W L Gore & Associates is recalling GORE CARDIOFORM Septal Occluder devices (REF/Catalogue Number GSXE0025, 25 mm diameter). The devices are labeled with an incorrect expiration date of 3 years instead of the correct 2-year expiration date.
The mislabeling creates a risk that clinicians could use the devices beyond their actual safe lifespan if relying on the labeled expiration date. Approximately 1,268 units were affected across multiple U.S. states and internationally, including Australia, Austria, Canada, Switzerland, Germany, Denmark, Spain, France, United Kingdom, Greece, Ireland, Italy, Mexico, Netherlands, Norway, Portugal, Saudi Arabia, and Sweden.
Healthcare providers should verify the actual 2-year expiration date and not use devices according to the 3-year date shown on the package. Facilities should review inventory of affected devices by serial number (22689696 through 23569078) and discard or quarantine any units that have exceeded the correct 2-year expiration date.
The recalled product
- Product
- REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617647 *Not distributed within the US
- Manufacturer
- W L Gore & Associates, Inc.
- Category
- Medical Device — Cardiac Implant
- Hazard
- mis-labeling
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
Distributed in 47 states:
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- FL
- GA
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- SC
- SD
- TN
- TX
- UT
- VA
- VT
- WA
- WI
- WV
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