Reported Jul 8, 2026 · Ongoing · Updated Sep 16, 2026
GORE� TAG� Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes…
W L Gore & Associates, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: W L Gore & Associates, Inc. · 1505 N 4th St · Flagstaff, AZ · 86004-5867
Is this the product you have?
- GORE� TAG� Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes
- Puerto Rico) and Canada
TSB080806ATSB081006ATSB081206ATSB081506ATSB081706ATSB121506ATSB121706ATSB122006A EMEA CountriesAustralia
- New Zealand
TSB080806ETSB081006ETSB081206ETSB081506ETSB081706ETSB121506ETSB121706E
- TSB122006E Japan
TSB080806JTSB081006JTSB081206JTSB081506JTSB081706JTSB121506JTSB121706J
- TSB122006J China and TaiwanTSB080806W, TSB081006W, TSB081206W, TSB081506W, TSB081706W, TSB121506W, TSB121706W, TSB122006W The GORE� TAG� Thoracic Branch Endoprosthesis is indicated for endovascular repair of lesions of the aortic arch and descending thoracic aorta, while maintaining flow into a single aortic arch branch vessel The GORE� TAG� Thoracic Branch Endoprosthesis is a modular device consisting of the Aortic Component (AC), the Side Branch (SB) Component, and an optional Aortic Extender (AE), and their respective delivery systems. These components may be used together as a stand-alone device or in conjunction with the GORE� TAG� Conformable Thoracic Endoprosthesis to accommodate the intended treatment site
- Lot codes and dates
- Catalog Number / UDI-DI CodeTSB081006A (00733132654369)
- Serial Numbers31602664
- Catalog Number / UDI-DI CodeTSB081006J (00733132662630)
- Serial Numbers
314218643142186531421870314323393143234031440637314406383144063931440640314406413144064231462061314620623146206331462064
- Catalog Number / UDI-DI CodeTSB081006W (00733132650866)
- Serial Numbers31530086
- Catalog Number / UDI-DI CodeTSB081206A (00733132654376)
- Serial Numbers
111 of 111 codes
312514803125148131251482312514843125696131256963312725213127252231272523312725253127252631272527312725283127252931272530312725313127253331272534312772063127720731277208312772093127721031280248312802493128025031280251312802523128025431280255312802563128025731289924312899253128992631289928312899293129054731290548312905493129055031301117313011183130781431312365313123663131236731319612313196133133203431332036313423633134236431345617313666433138754531395549313955503139787731397878
- Catalog Number / UDI-DI CodeTSB081206E (00733132640485)
- Serial Numbers
31253984312539853125398631253987312539883125398931253990312900533129337331293374
- Catalog Number / UDI-DI CodeTSB081206J (00733132662647)
- Serial Numbers
84 of 84 codes
312718093127181031271811312751363127513731275138312751393127514031277767312777683127776931277770312777713128531931285320312853213128988131289882312898833130112731301128313011293131121631311217313112183131562231315623313156243131562531371534313715353137153631371537313903973139039831390399313975683139756931397570314118613141186231411863314118643141186531411866314218713142187231421873314218743142187531421876314218773142187831421879314218803143874631438747314387483143874931438750
- Catalog Number / UDI-DI CodeTSB081206W (00733132650873)
- Serial Numbers
3124944031249441312494423125613231256133312561343125613531256136312561373125613831256139312561403125614131258012312580133125801431258015312580163126680431266805312668063127772531277726312777273127772831277729312762363127623731276238312762393127624031276241312850663128506731285068312897573128975831289759312897603128976131293955312939563129395731293958312939593129396031293961312939623129396331293964313659083140858031408581
- Catalog Number / UDI-DI CodeTSB081506A (00733132654383)
- Serial Numbers
109 of 109 codes
312725383127254031272542312725433127254431272545312725463127254731272548312725493127255231272553312684173126841831268423312684263128028231280284312802853128029031280291312802923128029331280295312899313128993231289934312899353129969631299697312996993130936531309366313128933131289431312895313128963131961931319620313196243131962531325034313250363132503731332048313320493133205031335377313353783133537931335380313353813133538231335383313353853136323231363236313666453136664631388732
- Catalog Number / UDI-DI CodeTSB081506W (00733132644414)
- Serial Numbers31274125 31274126 31274127 31319417 31319418 31319419 31367372
- Catalog Number / UDI-DI CodeTSB121506A (00733132654406)
- Serial Numbers
31320042313200433132004431332059313320603134236931342371314123133141231431412316314123173141232031416880314168813141688231416883314168853142018631420187314201883142018931420190314454343144543531445437314454383146223831462239314622413146544231465446314724773147247831484427314844293148443131484432314844333149378231493783315066923150669331506695315346953153469831534699315368193158691931586921315869223158692531586928
- Catalog Number / UDI-DI CodeTSB121506W (00733132650897)
- Serial Numbers31380152
- Catalog Number / UDI-DI CodeTSB121706A (00733132654413)
- Serial Numbers31541449
- Catalog Number / UDI-DI CodeTSB122006A (00733132654420)
- Serial Numbers
312997083129971031299711313093863132605531326057315341823153418331534185315524063155240731591151315955513159555231595553
- Catalog Number / UDI-DI CodeTSB122006E (00733132640539)
- Serial Numbers31298916 31298917 31311743 31320146 31405481 31405482 31405483
- Amount recalled
- 467 devices
Where it was sold
Why it was recalled
Due to catheter separation
This product could cause temporary or reversible health problems — stop using it.
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