United StatesGORE TAG Thoracic Branch Endoprosthesis Side Branch Component devices (catalog numbers listed by region, e.g., TSB080806A, TSB081006A, TSB081206A and corresponding regional variants ending in A, E, J, W) are affected. They were recalled because of catheter separation.
What's being recalled
GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB121706A, TSB122006A EMEA Countries, Australia, New Zealand: TSB080806E, TSB081006E, TSB081206E, TSB081506E, TSB081706E, TSB121506E, TSB121706E, TSB122006E Japan: TSB080806J, TSB081006J, TSB081206J, TSB081506J, TSB081706J, TSB121506J, TSB121706J, TSB122006J China and Taiwan: TSB080806W, TSB081006W, TSB081206W, TSB081506W, TSB081706W, TSB121506W, TSB121706W, TSB122006W The GORE¿ TAG¿ Thoracic Branch Endoprosthesis is indicated for endovascular repair of lesions of the aortic arch…
Recalling firm: W L Gore & Associates, Inc., Flagstaff, AZ, United States.
How to identify it
Catalog Number / UDI-DI Code: TSB081006A (00733132654369) Serial Numbers: 31602664 Catalog Number / UDI-DI Code: TSB081006J (00733132662630) Serial Numbers: 31421864 31421865 31421870 31432339 31432340 31440637 31440638 31440639 31440640 31440641 31440642 31462061 31462062 31462063 31462064 Catalog Number / UDI-DI Code: TSB081006W (00733132650866) Serial Numbers: 31530086 Catalog Number / UDI-DI Code: TSB081206A (00733132654376) Serial Numbers: 31251480 31251481 31251482 31251484 31256961 31256963 31272521 31272522 31272523 31272525 31272526 31272527 31272528 31272529 31272530 31272531 31272533 31272534 31277206 31277207 31277208 31277209 31277210 31280248 31280249 31280250 31280251 31280252 31280254 31280255 31280256 31280257 31289924 31289925 31289926 31289928 31289929 31290547 31290548 31290549 31290550 31301117 31301118 31307814 31312365 31312366 31312367 31319612 31319613 31332034 31332036 31342363 31342364 31345617 31366643 31387545 31395549 31395550 31397877 31397878 31407669 31407670 31407674 31407675 31407676 31407677 31407678 31410726 31416877 31430425 31430426 31430428 31432234 31432235 31432236 31432239 31432240 31432241 31435513 31435514 31440731 31440734 31462230 31465437 31465438 31465440 31472456 31472457 31472459 31479940 31493741 31493742 31499222 31499223 31499226 31563552 31563560 31572876 31572880 31572882 31572891 31572892 31581245 31581253 31581254 31611436 31611437 31611441 31642687 31642688 31642689 Catalog Number / UDI-DI Code: TSB081206E (00733132640485) Serial Numbers: 31253984 31253985 31253986 31253987 31253988 31253989 31253990 31290053 31293373 31293374 Catalog Number / UDI-DI Code: TSB081206J (00733132662647) Serial Numbers: 31271809 31271810 31271811 31275136 31275137 31275138 31275139 31275140 31277767 31277768 31277769 31277770 31277771 31285319 31285320 31285321 31289881 31289882 31289883 31301127 31301128 31301129 31311216 31311217 31311218 31315622 31315623 31315624 31315625 31371534 31371535 31371536 31371537 31390397…
The hazard
Due to catheter separation
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - U.S. Nationwide distribution including in the states and territories of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, and WI. The countries of United Arab Emirates, Australia, Austria, Canada, Switzerland, China, Cyprus, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Israel, Italy, Japan, Luxembourg, Monaco, Malta, Netherlands, Norway, New Zealand, Poland, Portugal, Saudi Arabia, Slovakia, Sweden, and Taiwan.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)