510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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Z-0260-2027

Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130; Material Number: M001195840

Boston Scientific Cork, Ltd. / initiated 2026-09-16 / Open, Classified
FDA source (opens on fda.gov)

Recall record

Recall number
Z-0260-2027
Status
Open, Classified
Initiated
Posted
Recalling firm
Boston Scientific Cork, Ltd.
Product
Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130; Material Number: M001195840
Product code
KRA Catheter, Continuous Flush
Reason for recall
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.
FDA root cause
Process control
Action
On September 16, 2026, Urgent Medical Device Removal - Immediate Action Required letters were sent to customers. Actions to be taken: 1. Immediately stop further use or distribution and segregate affected product (see Attachment 1 for identification of the affected devices). 2. Forward this notice to relevant personnel and any facilities to which the product was transferred. 3. Continue to follow the standard of practice when monitoring patients treated with the product. 4. Complete and return the enclosed Reply Verification Tracking Form per the included instructions. 5. Return product to Boston Scientific in accordance with the enclosed instructions.
Quantity in commerce
7945
Distribution
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.
Product codes and lots
Material Number: M001195840; UDI-DI: 08714729839774; Batch Numbers: 37818448, 37818450, 37849391, 37849392, 37849393, 37849394, 37914481, 37914482, 37914483, 37957749, 37957750, 37957751, 37957752, 37981353, 37981354, 37981355, 37981356, 38002451, 38002452, 38002453, 38002454, 38002455, 38002456, 38022642, 38022643, 38022644, 38022645, 38049173, 38065519, 38065520, 38065522, 38065523, 38065524, 38065525, 38065527, 38065528, 38065529, 38065531, 38065532, 38065533, 38106627, 38106628, 38106630, 38149832, 38149833, 38149834, 38149835, 38149836, 38181976, 38181977, 38181978, 38181979, 38181980, 38259490, 38259491, 38290729, 38290730, 38290731, 38290732, 38290733, 38350328, 38350329, 38350330, 38350331, 38350332, 38350333, 38362203, 38362205, 38362206, 38531121, 38629563, 38649510, 38687335, 38708448, 38708449, 38708450, 38708451, 38769965, 38769966, 38769967, 38827707, 38827708, 38876170, 38904804, 38932706, 38932707, 38934432, 38934433, 38934434, 39029655, 39029656, 39029657, 39029658, 39074458, 39074459, 39074600, 39074601, 39074602, 39074603, 39140987, 39140988, 39140989, 39140990, 39140991, 39140992, 39187842, 39187844, 39187845, 39187846, 39219921, 40466468, 40466469, 40466470, 40466588, 40466589, 40466607, 40466608, 40466609, 40466610, 40471679, 40471960, 40471961, 40476398, 40476480, 40476481, 40476482, 40485645, 40485722, 40485723, 40485724, 40485729, 40485730, 40485731, 40493372, 40493373, 40493374, 40493375, 40493376, 40493377, 40493378, 40493379, 40493380, 40493381, 40494944, 40494945, 40494946, 40502255, 40502258, 40502259, 40504658, 40504659, 40504840, 40508312, 40508313, 40510558, 40510559, 40512915, 40512916, 40512918, 40513100, 40513101, 40521985, 40521986, 40521987, 40521988, 40521989, 40523930, 40523931, 40523932, 40523933, 40523934, 40523935, 40523936, 40523937, 40526446, 40526447, 40526448, 40526449, 40526450, 40526451, 40528687, 40528688, 40528689, 40528690, 40528691, 40533346, 40533347, 40533348, 40533349, 40535973, 40535974, 40535976, 40539619;