Reported Sep 15, 2021 · Ongoing
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
Micro Therapeutics Inc.,
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: Micro Therapeutics Inc, · 9775 Toledo Way · Irvine, CA · 92618-1811
Is this the product you have?
- EV3 Pipeline Flex Embolization Device with Flex Shield Technology
- Lot codes and dates
85 of 85 products
Products covered by this recall Model / number Barcodes Product as published PED2-250-1000847536002029Lot Numbers: A816342 A827596 A834390 A849720 Product/REF/UDI: PED2-250-14 PIPELINE FLEX SHIELD PED2-250-1400847536002043Lot Numbers: A812725 A832008 A833123 A846924 Product/REF/UDI: PED2-250-16 PIPELINE FLEX SHIELD PED2-250-1600847536002050Lot Numbers: A816342 A826273 A827599 A832010 A842690 A846927 Product/REF/UDI: PED2-250-20 PIPELINE FLEX SHIELD PED2-250-2000847536002074Lot Numbers: A810946 A816343 A816343 A819116 Product/REF/UDI: PED2-275-12 PIPELINE FLEX SHIELD PED2-275-1200847536002098Lot Number: A916293 Product/REF/UDI: PED2-275-14 PIPELINE FLEX SHIELD PED2-275-1400847536002104Lot Numbers: A830303 A830304 A846930 A846931 Product/REF/UDI: PED2-275-16 PIPELINE FLEX SHIELD PED2-275-1600847536002111Lot Numbers: A819135 A846932 A855391 A859750 A869908 A871955 A873194 Product/REF/UDI: PED2-275-18 PIPELINE FLEX SHIELD PED2-275-1800847536002128Lot Numbers: A810946 A821512 A836546 A849721 Product/REF/UDI: PED2-275-20 PIPELINE FLEX SHIELD PED2-275-2000847536002135Lot Numbers: A827600 A842691 Product/REF/UDI: PED2-300-10 PIPELINE FLEX SHIELD PED2-300-1000847536002142Lot Numbers: A833123 A836549 Product/REF/UDI: PED2-300-12 PIPELINE FLEX SHIELD PED2-300-1200847536002159Lot Number: A821514 Product/REF/UDI: PED2-300-14 PIPELINE FLEX SHIELD PED2-300-1400847536002166Lot Numbers: A818298 A916294 Product/REF/UDI: PED2-300-16 PIPELINE FLEX SHIELD PED2-300-1600847536002173Lot Numbers: A826275 A830766 A834391 A846933 Product/REF/UDI: PED2-300-18 PIPELINE FLEX SHIELD PED2-300-1800847536002180Lot Numbers: A818299 A827602 A836550 A842691 A847555 Product/REF/UDI: PED2-300-20 PIPELINE FLEX SHIELD PED2-300-2000847536002197Lot Number: A916295 Product/REF/UDI: PED2-300-25 PIPELINE FLEX SHIELD PED2-300-2500847536002685Lot Numbers: A818459 A826923 A829033 A848678 Product/REF/UDI: PED2-300-30 PIPELINE FLEX SHIELD PED2-300-3000847536002692Lot Numbers: A829034 A848679 Product/REF/UDI: PED2-300-35 PIPELINE FLEX SHIELD PED2-300-3500847536002708Lot Number: A822215 Product/REF/UDI: PED2-325-10 PIPELINE FLEX SHIELD PED2-325-1000847536002203Lot Numbers: A817764 A827602 A847556 Product/REF/UDI: PED2-325-14 PIPELINE FLEX SHIELD PED2-325-1400847536002227Lot Numbers: A832011 A832016 Product/REF/UDI: PED2-325-16 PIPELINE FLEX SHIELD - Amount recalled
- 16,169 total devices for all model/products
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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