Pipeline Flex Embolization Device
Check against the official notice below — it lists the full affected range.
Micro Therapeutics Inc. is recalling 16,169 Pipeline Flex Embolization Devices due to potential push wire fractures that can occur in the delivery system during use. The fractures appear in the spiral cut area of the Hypotube component. The recalled devices were distributed across all U.S. states and Puerto Rico, as well as multiple countries in Latin America and Europe, including Argentina, Brazil, Canada, Mexico, and various European nations.
The recall affects multiple Pipeline Flex models in different sizes, identified by specific product codes (PED-250-10 through PED-275-14) and their associated lot numbers. The source document does not specify a remedy or instructions for what affected consumers should do in response to this recall.
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: PED-250-10 PIPELINE FLEX 2.50MM X 10MM PED-250-10 00847536014343 Lot Numbers: A815698 A835648 A837027 A837028 A856681 A867213 A877526 A879720 A885865 A887304 A889034 A894160 A898559 A910394 A911797 A915537 Product/REF/UDI: PED-250-12 PIPELINE FLEX 2.50MM X 12MM PED-250-12 00847536014374 A813321 A819204 A822948 A848725 A876747 A879721 A887306 A887308 A887311 A887311 A887314 A887314 A894161 A894162 A894163 A904254 A908288 B005860 B017059 Product/REF/UDI: PED-250-14 PIPELINE FLEX 2.50MM X 14MM PED-250-14 00847536014404 Lot Numbers: A813323 A822948 A839880 A854063 A859756 A879723 A879724 A889035 A889037 A902102 A906073 A914143 A915539 Product/REF/UDI: PED-250-16 PIPELINE FLEX 2.50MM X 16MM PED-250-16 00847536014435 Lot Numbers: A822949 A829045 A843379 A882136 A887316 A889039 A894609 A909355 B005846 Product/REF/UDI: PED-250-18 PIPELINE FLEX 2.50MM X 18MM PED-250-18 00847536014466 Lot Numbers: A867848 A877526 A877527 A877532 A879725 A887317 A910395 B007408 Product/REF/UDI: PED-250-20 PIPELINE FLEX 2.50MM X 20MM PED-250-20 00847536014497 Lot Numbers: A867214 A877533 A885866 A885867 A887318 Product/REF/UDI: PED-275-10 PIPELINE FLEX 2.75MM X 10MM PED-275-10 00847536014527 Lot Numbers: A854607 A867215 A900753 A912447 B002744 Product/REF/UDI: PED-275-12 PIPELINE FLEX 2.75MM X 12MM PED-275-12 00847536014558 Lot Numbers: A822950 A864485 A866005 A873187 A873201 A885868 A885869 A906074 A909356 Product/REF/UDI: PED-275-14 PIPELINE FLEX 2.75MM X 14MM PED-275-14 00847536014589
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.