GORE CARDIOFORM Septal Occluder devices labeled with incorrect expiration date
W L Gore recalled 846 GORE CARDIOFORM Septal Occluder units labeled with a 3-year expiration instead of the correct 2-year expiration.
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 critical labeling error on a medical device where the labeled expiration date exceeds the actual safe shelf life. This represents a risk-of-harm product where the device could be used beyond its intended expiration without the user's knowledge. Although no adverse events are reported, the potential for patient harm justifies a High severity rating.
Plain-English summary
W L Gore & Associates, Inc. is recalling 846 units of GORE CARDIOFORM SEPTAL OCCLUDER devices (30 mm diameter, 75 cm catheter length, 10 Fr delivery profile). The affected devices are labeled with a 3-year expiration date when the correct expiration date is 2 years.
This labeling error could result in the device being used beyond its actual intended shelf life. Healthcare providers relying on the labeled expiration date may use a device that has already exceeded its safe lifespan, potentially compromising device integrity and patient safety.
The affected devices were distributed to all 50 US states plus Washington DC, and internationally to Australia, Austria, Canada, Switzerland, Germany, Denmark, Spain, France, United Kingdom, Greece, Ireland, Italy, Mexico, Netherlands, Norway, Portugal, Saudi Arabia, and Sweden. Serial numbers affected range from 22689696 through 23569078. No adverse events have been reported.
Healthcare providers should verify the expiration date on their GORE CARDIOFORM SEPTAL OCCLUDER inventory and contact W L Gore & Associates, Inc. for instructions regarding affected units.
The recalled product
- Product
- REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661 *Not distributed within the US
- Manufacturer
- W L Gore & Associates, Inc.
- Hazard
- expiration-dating-error
- device-integrity-risk
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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