Lower risk Medical device recall · FDA · Published September 2, 2021

W L Gore Recalls Cardioform Septal Occluder with Incorrect Expiration Date

W L Gore recalls Cardioform Septal Occluder 30mm with 3-year expiration label instead of 2-year. Product sold outside US with specific serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0172-2022Medical device W L Gore ›

Lower-risk recall

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

Take action

Contact the company

Recalling firmW L Gore & Associates, Inc.3750 W Kiltie Ln · Flagstaff, AZ 86005-8712

✎ GovInfoNow plain-language explainer

W L Gore is recalling a specific type of heart valve device due to an incorrect expiration date label. This could lead to product expiration issues if used after the intended timeframe. Read more at govinfonow.com/recall/61835-w-l-gore-recalls-cardioform-septal-occluder-with-incorrect-expiration.

Source Summary by GovInfoNow · govinfonow.com/recall/61835-w-l-gore-recalls-cardioform-septal-occluder-with-incorrect-expiration · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0172-2022

Cite this page

“W L Gore Recalls Cardioform Septal Occluder with Incorrect Expiration Date.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61835-w-l-gore-recalls-cardioform-septal-occluder-with-incorrect-expiration. Based on FDA recall #Z-0172-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0172-2022%22&limit=1).

W L Gore & Associates, Inc. recalled GORE CARDIOFORM SEPTAL OCCLUDER units because they contain an incorrect expiration date, the FDA said on Sept. 2, 2021. The device is labeled with a three-year expiration instead of two years.

How to tell if you have it

Brand: W L Gore
Product: GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm
REF/Catalogue Number: GSX0030H
Delivery Profile: 10 Fr
UDI: 00733132648948
Serial numbers: 22689696 through 23569078
Quantity: 15 units

The hazard

The septal occluders contain the incorrect expiration date. The product is labeled with a three-year expiration date instead of the required two-year expiration date.

Context

GovInfoNow's records show W L Gore & Associates, Inc. has 18 other recalls on record since Sept. 25, 2017. Recent similar product recalls include Cook Medical Multipurpose Drainage Catheter (March 5, 2026), BD Ready-to-Use Hydrophilic Catheter (Nov. 29, 2025), and Berlin Heart Pediatric VAD Blood Pump Valves (April 24, 2026).

How to tell if you have this one

Check for the product name 'GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter' with serial numbers between 22689696 and 23569078. The product is only sold outside the US.

Brand
W L Gore
Category
Medical device

FDA recall event · 9 products

All 9 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US: 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 OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE

Recall number	Product, codes & lots	Quantity
Z-0164-2022	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; serial numbers 22689696 through 23569078	2,238 units
Z-0165-2022	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; serial numbers 22689696 through 23569078	138 units
Z-0166-2022	REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025 *Not distributed within the US; serial numbers 22689696 through 23569078	N/A
Z-0167-2022	REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617630 *Not distributed within the US; serial numbers 22689696 through 23569078	95 units
Z-0168-2022	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; serial numbers 22689696 through 23569078	1268 unit
Z-0169-2022	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; serial numbers 22689696 through 23569078	846 units
Z-0170-2022	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; serial numbers 22689696 through 23569078	187 units
Z-0171-2022	REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within the US; serial numbers 22689696 through 23569078	222 units
Z-0172-2022	REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within the US; serial numbers 22689696 through 23569078	15 units

Based on the official FDA remedy

What to do — step by step

Check Expiration Date
Verify the expiration date on the product label; it should be 2 years instead of 3.

Where it went and when

Where it was distributed

Distributed in 46 states and D.C..

FDA distribution: “US: 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 OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 2 months after the firm started it.

Sep 2, 2021Firm started the recall
Oct 22, 2021FDA classified it Class II
Nov 3, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this product safe to use?

The product may be safe if used before the correct expiration date, but the label error could lead to premature expiration.

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Link to this recall

<a href="https://govinfonow.com/recall/61835-w-l-gore-recalls-cardioform-septal-occluder-with-incorrect-expiration">W L Gore Recalls Cardioform Septal Occluder with Incorrect Expiration Date (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0172-2022 (September 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0172-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.