EV3 Pipeline Flex Embolization Device with Flex Shield Technology
Check against the official notice below — it lists the full affected range.
Micro Therapeutics Inc. has recalled the EV3 Pipeline Flex Embolization Device with Flex Shield Technology due to potential push wire fractures that can occur during use. The fractures develop in the spiral cut area of the Hypotube, which is part of the delivery system. A total of 16,169 devices across multiple product models and lot numbers have been affected by this recall. The devices were distributed throughout the United States, Puerto Rico, and multiple countries in Central and South America and Europe.
The recall involves 13 different Pipeline Flex Shield product models with various lot numbers. The specific products recalled include models with references ranging from PED2-250-10 through PED2-300-16, each identified by a unique UDI code and specific lot numbers. The recall record does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.
Reason for recall: Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube. Distribution: U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV O.U.S.: Argentina, Brazil Canada, Chile, Colombia, Ecuador, Mexico, Peru, Austria, Belgium, Canary Island, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ir Quantity: 16,169 total devices for all model/products Lot/code info: Product/REF/UDI: PED2-250-10 PIPELINE FLEX SHIELD PED2-250-10 00847536002029 Lot Numbers: A816342 A827596 A834390 A849720 Product/REF/UDI: PED2-250-14 PIPELINE FLEX SHIELD PED2-250-14 00847536002043 Lot Numbers: A812725 A832008 A833123 A846924 Product/REF/UDI: PED2-250-16 PIPELINE FLEX SHIELD PED2-250-16 00847536002050 Lot Numbers: A816342 A826273 A827599 A832010 A842690 A846927 Product/REF/UDI: PED2-250-20 PIPELINE FLEX SHIELD PED2-250-20 00847536002074 Lot Numbers: A810946 A816343 A816343 A819116 Product/REF/UDI: PED2-275-12 PIPELINE FLEX SHIELD PED2-275-12 00847536002098 Lot Number: A916293 Product/REF/UDI: PED2-275-14 PIPELINE FLEX SHIELD PED2-275-14 00847536002104 Lot Numbers: A830303 A830304 A846930 A846931 Product/REF/UDI: PED2-275-16 PIPELINE FLEX SHIELD PED2-275-16 00847536002111 Lot Numbers: A819135 A846932 A855391 A859750 A869908 A871955 A873194 Product/REF/UDI: PED2-275-18 PIPELINE FLEX SHIELD PED2-275-18 00847536002128 Lot Numbers: A810946 A821512 A836546 A849721 Product/REF/UDI: PED2-275-20 PIPELINE FLEX SHIELD PED2-275-20 00847536002135 Lot Numbers: A827600 A842691 Product/REF/UDI: PED2-300-10 PIPELINE FLEX SHIELD PED2-300-10 00847536002142 Lot Numbers: A833123 A836549 Product/REF/UDI: PED2-300-12 PIPELINE FLEX SHIELD PED2-300-12 00847536002159 Lot Number: A821514 Product/REF/UDI: PED2-300-14 PIPELINE FLEX SHIELD PED2-300-14 00847536002166 Lot Numbers: A818298 A916294 Product/REF/UDI: PED2-300-16 PIPELINE FLEX SHIELD PED2-300-16 00847536002173 Lot Numbers: A826
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.