CLASS II ONGOING Device recall · Reported 3 Nov 2021 · FDA Enforcement Report

REF/Catalogue Number GSXE0020, Gore Cardioform Septal Occluder 20 mm recalled

W L Gore & Associates is recalling REF/Catalogue Number GSXE0020, Gore Cardioform Septal Occluder 20 mm, distributed in 47 states. The recall was initiated on 2 Sep 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesserial numbers 22689696 through 23569078

Quantity recalled95 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0167-2022
FDA event ID: 88683
Recalling firm: W L Gore & Associates, Flagstaff, AZ
Classification: Class II
Status: Ongoing
Recall initiated: 2 Sep 2021
FDA classified: 22 Oct 2021
Reported: 3 Nov 2021
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

2 Sep 2021	Recall initiated by company
22 Oct 2021	Classified by FDA	+50 days
3 Nov 2021	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine

Questions about this recall

Why was it recalled?

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

Which lots are affected?

serial numbers 22689696 through 23569078

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

8 other products · FDA event 88683

This product is part of a recall event; the main page for the event is REF/Catalogue Number GSX0030H, Gore Cardioform Septal Occluder 30 mm recalled.

Reported	Class	Recall	Company	Reason	Where
3 Nov 2021	CLASS II	REF/Catalogue Number GSX0030H, Gore Cardioform Septal Occluder 30 mm recalled	W L Gore & Associates	Other	47 states
3 Nov 2021	CLASS II	REF/Catalogue Number GSX0025A, Gore Cardioform Septal Occluder 25 mm recalled	W L Gore & Associates	Other	47 states
3 Nov 2021	CLASS II	REF/Catalogue Number GSXE0030, Gore Cardioform Septal Occluder 30 mm recalled	W L Gore & Associates	Other	47 states
3 Nov 2021	CLASS II	REF/Catalogue Number GSX0020A, Gore Cardioform Septal Occluder 20 mm recalled	W L Gore & Associates	Other	47 states
3 Nov 2021	CLASS II	REF/Catalogue Number GSXE0025B recalled by W L Gore & Associates	W L Gore & Associates	Other	47 states
3 Nov 2021	CLASS II	REF/Catalogue Number GSXE0030B recalled by W L Gore & Associates	W L Gore & Associates	Other	47 states
3 Nov 2021	CLASS II	REF/Catalogue Number GSX0030A, Gore Cardioform Septal Occluder 30 mm recalled	W L Gore & Associates	Other	47 states
3 Nov 2021	CLASS II	REF/Catalogue Number GSXE0025, Gore Cardioform Septal Occluder 25 mm recalled	W L Gore & Associates	Other	47 states

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