United StatesWhat's being recalled
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/105; Material Number: M001195200
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/130; Material Number: M001195210
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/155; Material Number: M001195220
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/105; Material Number: M001195230
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/130; Material Number: M001195240
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/155; Material Number: M001195250
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105; Material Number: M001195260
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/130; Material Number: M001195270
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/155; Material Number: M001195280
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/130; Material Number: M001195300
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/155; Material Number: M001195310
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/130; Material Number: M001195320
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/155; Material Number: M001195330
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/130; Material Number: M001195340
And 26 more products.
Recalling firm: Boston Scientific Cork, Ltd., Cork, Ireland.
How to identify it
Material Number: M001195200; UDI-DI: 08714729839316; Batch Numbers: 37942457, 37999053, 38224527, 38304916, 38415911, 38687159, 38707977, 38916519, 39029416, 39029419, 39029640, 39092278, 40476286, 40479386, 40523958, 40525677; Material Number: M001195210; UDI-DI: 08714729839323; Batch Numbers: 37914435, 37914436, 37956674, 37981343, 37981344, 38022632, 38022633, 38022634, 38149673, 38181211, 38224528, 38259475, 38259476, 38290713, 38290714, 38290715, 38290716, 38290717, 38399232, 38446223, 38479515, 38506196, 38530446, 38530447, 38629332, 38629333, 38647617, 38647618, 38649501, 38649508, 38687327, 38708440, 38708441, 38745184, 38769513, 38769514, 38934430, 39189795, 39189798, 40466471, 40466472, 40482683, 40482684, 40482685, 40487838, 40487839, 40487900, 40487954, 40487955, 40487956, 40487957, 40501048, 40501049, 40514122, 40514123, 40514222, 40514223, 40533342, 40533344, 40536165, 40536166; Material Number: M001195220; UDI-DI: 08714729839330; Batch Numbers: 37981345, 38022666, 38629565, 38629566, 38708453, 38745192, 38800928, 38800929, 38916517, 38937262, 38990881, 39074440, 39141261, 40482690, 40482691, 40485783, 40485784, 40489060, 40507284, 40510556, 40512867, 40512868, 40512869, 40512993, 40512994, 40512995, 40513031, 40513032, 40539143, 40539144; Material Number: M001195230; UDI-DI: 08714729839347; Batch Numbers: 37818205, 37942458, 37956675, 37981346, 38002441, 38224529, 38224530, 38304917, 38304918, 38415912, 38484288, 38506191, 38595896, 38629330, 38647611, 38647613, 38687220, 38687221, 38707976, 38876166, 38970274, 38970936, 39092279, 39092680, 40484896, 40484897, 40484952, 40523918, 40523919, 40525673, 40525674, 40525675, 40525676, 40531394, 40531395, 40531396; Material Number: M001195240; UDI-DI: 08714729839354; Batch Numbers: 37818206, 37818207, 37818208, 37818209, 37849382, 37849383, 37849384, 37849385, 37849386, 37849387, 37849388, 37849389, 37914437, 37914438, 37914439, 37914460, 37914461, 37956676, 37956677, 37981347, 38002442, 38022635…
The hazard
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
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 distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Mexico, Moldova, Netherlands, New Zealand, Norway, Panama, PERU, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, T¿rkiye, UAE, United Kingdom.
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)