Reported Sep 15, 2021 · Ongoing
Pipeline Flex Embolization Device
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?
- Pipeline Flex Embolization Device
- Lot codes and dates
95 of 95 products
Products covered by this recall Model / number Barcodes Product as published PED-250-1000847536014343Lot 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-250-1200847536014374A813321 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-250-1400847536014404Lot 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-250-1600847536014435Lot Numbers: A822949 A829045 A843379 A882136 A887316 A889039 A894609 A909355 B005846 Product/REF/UDI: PED-250-18 PIPELINE FLEX 2.50MM X 18MM PED-250-1800847536014466Lot Numbers: A867848 A877526 A877527 A877532 A879725 A887317 A910395 B007408 Product/REF/UDI: PED-250-20 PIPELINE FLEX 2.50MM X 20MM PED-250-2000847536014497Lot Numbers: A867214 A877533 A885866 A885867 A887318 Product/REF/UDI: PED-275-10 PIPELINE FLEX 2.75MM X 10MM PED-275-1000847536014527Lot Numbers: A854607 A867215 A900753 A912447 B002744 Product/REF/UDI: PED-275-12 PIPELINE FLEX 2.75MM X 12MM PED-275-1200847536014558Lot Numbers: A822950 A864485 A866005 A873187 A873201 A885868 A885869 A906074 A909356 Product/REF/UDI: PED-275-14 PIPELINE FLEX 2.75MM X 14MM PED-275-1400847536014589Lot Numbers: A812097 A822951 A861761 A873187 A873201 A873204 A873205 A874035 A874035 A883589 A885870 A885871 A885872 A906076 A906725 Product/REF/UDI: PED-275-16 PIPELINE FLEX 2.75MM X 16MM PED-275-1600847536014619Lot Numbers: A813324 A877534 A883590 A894164 A894611 B005862 Product/REF/UDI: PED-275-18 PIPELINE FLEX 2.75MM X 18MM PED-275-1800847536014640Lot Numbers: A823540 A876748 A882137 A894613 Product/REF/UDI: PED-275-20 PIPELINE FLEX 2.75MM X 20MM PED-275-2000847536014671Lot Numbers: A864487 A866006 A896158 A896159 A900754 Product/REF/UDI: PED-300-10 PIPELINE FLEX 3.00MM X 10MM PED-300-1000847536014701Lot Numbers: A823542 A870630 A878414 A879726 A894613 A910395 Product/REF/UDI: PED-300-12 PIPELINE FLEX 3.00MM X 12MM PED-300-1200847536014732Lot Numbers: A839881 A848726 A863674 A863675 A865228 A866008 A896160 A902103 A903567 A911798 Product/REF/UDI: PED-300-14 PIPELINE FLEX 3.00MM X 14MM PED-300-1400847536014763Lot Numbers 008475360147630084753601476300847536014763— 008475360147630084753601476300847536014763— 008475360147630084753601476300847536014763Product/REF/UDI: PED-300-16 PIPELINE FLEX 3.00MM X 16MM PED-300-1600847536014794Lot Numbers: A829045 A850778 A852544 A865229 A866009 A896161 A902104 A902106 A906077 B008202 Product/REF/UDI: PED-300-18 PIPELINE FLEX 3.00MM X 18MM PED-300-1800847536014824Lot Numbers: A835649 A850780 A852545 A852546 A867713 A902106 A902107 Product/REF/UDI: PED-300-20 PIPELINE FLEX 3.00MM X 20MM - 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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