GORE CARDIOFORM Septal Occluder Recalled for Incorrect Expiration Date Labeling
W L Gore & Associates is recalling 187 units of GORE CARDIOFORM Septal Occluders because they are labeled with a 3-year expiration date instead of the correct 2-year expiration date. Using the device beyond its actual shelf life could compromise its safety and effectiveness.
What this means for you
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 FDA Class II recall involves a cardiac implant device with mislabeled expiration date. As a risk-of-harm product, using the device beyond its actual safe shelf life could compromise patient safety and device effectiveness. No illnesses or injuries have been reported.
Plain-English summary
W L Gore & Associates, Inc. is recalling 187 units of the GORE CARDIOFORM Septal Occluder (25 mm diameter, catalogue number GSXE0025B) due to an expiration date labeling error. The affected product is labeled with a 3-year expiration date when the correct expiration date is 2 years.
The GORE CARDIOFORM Septal Occluder is a cardiac implant device used in procedures to treat certain heart defects. Using this device beyond its actual expiration date could compromise its sterility and safety. Affected units have serial numbers ranging from 22689696 through 23569078.
The recalled devices have been distributed to healthcare facilities in the United States and internationally, including Canada, Mexico, and multiple European countries.
The recalled product
- Product
- REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620111 *Not distributed within the US
- Manufacturer
- W L Gore & Associates, Inc.
- Category
- Medical Device — Cardiac implant
- Hazard
- mislabeling
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
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03