The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Products

Flexor Check-Flo Introducers

• Catalog and Lot  numbers: See Full List 
• Manufacturing Dates: February 17, 2020 to September 29, 2020
• Distribution Dates: May 23, 2020 to November 17, 2020
• Devices Recalled in the U.S.: 37,326
• Date Initiated by Firm: November 24, 2020

Device Use

The Cook Medical Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers (Shuttle Select) are catheters that have a coated shaft, a valve, a dilator, and markers that show up on an x-ray. The catheters help insert other medical devices used for therapy or diagnosis into the vessels, except those of the heart and brain, during surgery or other procedures.

Fig. 1: Pictures of the Flexor Check-Flo Introducer and the Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select) with a red arrow showing where separation usually happens (proximal bond site).

Reason for Recall 

Cook Medical is recalling the Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers (Shuttle Select) because of an increased chance of separation at a specific point (proximal bond site) shown in Figure 1. If the device separates during use, this may lead to life-threatening adverse events.

Use of the affected product may cause serious adverse events, including longer procedure time, another procedure to take out a separated piece, blocking blood flow to vital organs, vessel injury, and bleeding.

There have been 57 complaints about this device issue and 14 reports of serious injuries. There have been no reported deaths.

Who May be Affected

• Health care providers using the affected Cook Medical introducers
• Patients who have procedures with the affected Cook Medical introducers

What to Do

On November 24, 2020, Cook Medical sent an Urgent Medical Device Recall notification letter to all affected customers letting them know the company is removing all devices potentially affected from the market.

The letter also provided the following instructions for customers:

• Return the affected products to Cook Medical with a copy of the Acknowledgement and Receipt Form.
• Share the Urgent Medical Device Recall notification letter with appropriate staff, including down to the user level, within the organization, or with any organization where the potentially affected devices have been transferred.
• Immediately report adverse events to Cook Medical Customer Relations.

Contact Information

Consumers with questions about this recall may contact Cook Medical by phone at (800) 457-4500 or (812) 339-2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by emailing [email protected].

Additional Resources

• Medical Device Recall Database Entry

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.

 

Full List of Flexor Check-Flo Introducers Catalog Numbers: DYB, KCFW-4.0-35-55-RB-HFANL0-HC, KCFW-4.0-35-55-RB-HFANL1-HC, KCFW-4.0-35-70-RB-HFANL0-HC, KCFW-5.0-35-55-RB-HFANL0-HC, KCFW-5.0-35-55-RB-HFANL1-HC, KCFW-5.0-35-70-RB-HFANL0-HC, KCFW-5.0-35-70-RB-HFANL1-HC, KCFW-6.0-35-55-RB-HFANL0-HC, KCFW-6.0-35-55-RB-HFANL1-HC, KCFW-6.0-35-70-RB-HFANL0-HC, KCFW-6.0-35-70-RB-HFANL1-HC, KCFW-7.0-35-55-RB-HFANL0-HC, KCFW-7.0-35-55-RB-HFANL1-HC, KCFW-7.0-35-70-RB-HFANL0-HC, KCFW-7.0-35-70-RB-HFANL1-HC, KCFW-8.0-35-55-RB-HFANL0-HC, KCFW-8.0-35-55-RB-HFANL1-HC, KCFW-8.0-35-70-RB-HFANL0-HC, KCFW-8.0-35-70-RB-HFANL1-HC

Full List of Lot Numbers: 13047587, 13089578, 13089579, 13126439, 13138927, 13197460, 13197462, 13203165, 13219551, 13221814, 13276233, 13312697, 13349024, 13380378, NS13094335, NS13226779, 13047588, 13050227, 13050229, 13130291, 13138925, 13203167, 13226780, 13276230, 13315165, 13332154, 13375204, 13375207, 13059453, 13059454, 13059455, 13059463, 13126438, 13197461, 13197463, 13207360, 13207367, 13234807, 13279094, 13346108, 13279103X, NS13059462, NS13260029, NS13304443, NS13312714, NS13346096, NS13352471, NS13372477, NS13410219, NS13426314, 13029693, 13029694, 13039738, 13039739, 13094338, 13094339, 13094340, 13094344, 13112923, 13112926, 13112927, 13119643, 13121403, 13124432, 13124433, 13126447, 13126448, 13126462, 13135821, 13135822, 13138934, 13138941, 13143088, 13143089, 13143090, 13145948, 13145949, 13153368, 13155283, 13158193, 13158194, 13158195, 13159695, 13163184, 13172666, 13172667, 13172668, 13189166, 13189167, 13189168, 13189171, 13194980, 13197476, 13197477, 13197478, 13197479, 13197480, 13202941, 13202942, 13202943, 13202944, 13202945, 13202946, 13202947, 13202948, 13202949, 13202950, 13202951, 13202953, 13207444, 13207445, 13207446, 13207447, 13207448, 13207449, 13207450, 13207451, 13207452, 13207453, 13207454, 13207455, 13207456, 13207457, 13207458, 13262315, 13262317, 13262321, 13265318, 13268024, 13268028, 13268030, 13268031, 13276235, 13276239, 13276242, 13279088, 13279105, 13281543, 13281544, 13288125, 13291883, 13301861, 13304456, 13318043, 13323500, 13323501, 13337799, 13337809, 13346109, 13352474, 13354244, 13357252, 13363227, 13366216, 13372480, 13391143, NS13108032, 13101181, 13121311, 13141330, 13153425, 13159709, 13170659, 13175451, 13186259, 13205335, 13205336, 13205337, 13205338, 13205339, 13205340, 13205341, 13214445, 13217109, 13217110, 13219549, 13226821, 13226822, 13226823, 13226824, 13226825, 13262316, 13262318, 13262383, 13262384, 13262385, 13262386, 13262387, 13262388, 13265309, 13265310, 13265311, 13265312, 13265313, 13265314, 13265315, 13265316, 13265317, 13265319, 13265321, 13268016, 13268018, 13268019, 13268020, 13268021, 13268022, 13268023, 13268025, 13268026, 13268027, 13268029, 13276232, 13276234, 13276236, 13276243, 13279089, 13315183, 13346074, 13346097, 13391157, NS13108062, 13089576, 13105053, 13130281, 13130282, 13135871, 13159711, 13159712, 13162740, 13166130, 13170660, 13175442, 13175443, 13186252, 13189278, 13192082, 13192083, 13192085, 13192086, 13192087, 13194970, 13194971, 13194973, 13194974, 13200438, 13203161, 13203162, 13203164, 13205342, 13205343, 13207358, 13207359, 13207361, 13207362, 13207363, 13207364, 13207365, 13207366, 13217123, 13219553, 13219554, 13223827, 13223828, 13226776, 13240001, 13243202, 13262322, 13276244, 13279106, 13304457, 13310767, 13315203, 13323502, 13329236, 13332175, 13337810, 13352475, 13360432, 13291884X, NS13077815, NS13077819, NS13105057, NS13105059, NS13192090, NS13226781, NS13315204, NS13376992, 13077814, 13089577, 13105054, 13140910, 13159710, 13162739, 13170661, 13186251, 13192084, 13194969, 13194972, 13200439, 13203160, 13203163, 13203166, 13214447, 13214449, 13217121, 13217122, 13219552, 13223826, 13223829, 13237651, 13276238, 13276245, 13286649, 13357239, 13366218, 13391145, NS13089580, NS13105058, NS13130292, NS13138931, NS13192091, NS13234809, NS13252367, NS13252368, NS13286655, NS13349016, NS13352450, NS13366219, NS13372482, NS13375232, NS13401834, NS13420125, 13135825, 13138939, 13138940, 13143095, 13143096, 13143097, 13150435, 13150438, 13150439, 13150440, 13150441, 13153382, 13153386, 13153387, 13155287, 13155288, 13155295, 13155296, 13158205, 13159698, 13159699, 13159701, 13159702, 13159703, 13159704, 13159705, 13166156, 13166160, 13166161, 13166162, 13172674, 13172679, 13172680, 13172681, 13175467, 13175468, 13175472, 13180819, 13186324, 13186325, 13186326, 13186329, 13186331, 13189188, 13189189, 13189190, 13189195, 13189196, 13189197, 13192073, 13197482, 13200417, 13200418, 13202955, 13202956, 13205308, 13207461, 13207462, 13207463, 13207464, 13211828, 13214464, 13214465, 13217129, 13217132, 13217133, 13217134, 13217135, 13217136, 13217137, 13221800, 13221806, 13221807, 13226796, 13226797, 13226798, 13226799, 13226800, 13226801, 13231821, 13237671, 13237672, 13240020, 13240021, 13240022, 13240023, 13240024, 13240025, 13246564, 13246565, 13256701, 13256707, 13256708, 13256709, 13256710, 13256711, 13262346, 13262347, 13268037, 13281553, 13281792, 13281793, 13281794, 13281795, 13281796, 13281797, 13281798, 13281799, 13291872, 13291875, 13294539, 13294540, 13294541, 13294542, 13297253, 13297254, 13297255, 13297256, 13297257, 13301868, 13301869, 13301870, 13304446, 13307201, 13307202, 13307203, 13307204, 13310756, 13310757, 13310758, 13312696, 13312701, 13312702, 13312703, 13315213, 13315214, 13315215, 13315216, 13318057, 13318058, 13320584, 13320592, 13320593, 13329231, 13329243, 13329244, 13329245, 13329247, 13332165, 13332166, 13334765, 13334766, 13334772, 13342864, 13342865, 13342866, 13346103, 13346104, 13346117, 13349025, 13349035, 13349036, 13352476, 13352477, 13352478, 13352479, 13352480, 13352481, 13352482, 13352483, 13357255, 13357256, 13360433, 13360434, 13360435, 13360436, 13360437, 13360439, 13366224, 13366225, 13372603, 13372604, 13375216, 13375217, 13375218, 13375219, 13375220, 13376996, 13380383, 13382713, 13382714, 13382715, 13382716, 13388322, 13388323, 13388324, 13391160, 13398852, 13423953, 13432833, 13446739, 13446740, 13455461, 13334771X, 13135824, 13140931, 13141304, 13141305, 13145950, 13145951, 13150436, 13150442, 13150443, 13153380, 13153383, 13153384, 13153385, 13155286, 13155289, 13155291, 13158203, 13158204, 13158208, 13162736, 13162737, 13163193, 13166157, 13166158, 13166159, 13172675, 13172676, 13172677, 13172678, 13175465, 13175466, 13175469, 13175470, 13175471, 13180815, 13180818, 13186322, 13186327, 13186328, 13189186, 13189191, 13189192, 13189193, 13189194, 13189198, 13189199, 13197483, 13200412, 13200413, 13200414, 13202954, 13205305, 13205306, 13207459, 13211825, 13211829, 13214442, 13214443, 13214444, 13217124, 13219557, 13219561, 13219562, 13219563, 13219564, 13221801, 13221808, 13221809, 13226802, 13226803, 13226804, 13229671, 13229678, 13229679, 13231822, 13234798, 13243204, 13243215, 13243216, 13243217, 13243218, 13243219, 13252359, 13260007, 13260018, 13262325, 13262326, 13265328, 13279083, 13279084, 13281529, 13281779, 13281780, 13281781, 13281782, 13288114, 13291865, 13294510, 13297239, 13301844, 13301845, 13301846, 13307175, 13307176, 13307177, 13310722, 13310723, 13310730, 13310731, 13312686, 13315170, 13315171, 13315172, 13318023, 13318033, 13318034, 13318035, 13332157, 13332158, 13334762, 13337772, 13337776, 13337777, 13337778, 13337779, 13337794, 13337795, 13342831, 13342837, 13342838, 13342839, 13342857, 13342858, 13342859, 13346085, 13348996, 13348997, 13348998, 13348999, 13349000, 13349001, 13352433, 13352440, 13352468, 13354239, 13354247, 13354248, 13354249, 13354250, 13354251, 13357224, 13357225, 13360405, 13360406, 13363206, 13363207, 13363215, 13363216, 13363217, 13369413, 13369414, 13369422, 13369423, 13372605, 13375223, 13375224, 13375225, 13376997, 13380390, 13380391, 13382717, 13384997, 13384998, 13391147, 13391148, 13391149, 13396148, 13398853, 13398854, 13398855, 13401842, 13407495, 13432838, 13375222X, 13143098, 13143099, 13143100, 13145952, 13145953, 13145955, 13150444, 13150446, 13159696, 13159697, 13159706, 13159708, 13166164, 13166165, 13166168, 13175473, 13175474, 13175480, 13178582, 13186336, 13192068, 13192074, 13211826, 13211827, 13214440, 13217125, 13217126, 13221802, 13223830, 13223831, 13229680, 13231823, 13231824, 13240026, 13240027, 13243203, 13246547, 13246566, 13252353, 13260022, 13260023, 13265330, 13265331, 13265335, 13268038, 13279080, 13281540, 13281800, 13281801, 13286656, 13286658, 13286659, 13286660, 13286662, 13288115, 13304447, 13306333, 13306334, 13307178, 13307189, 13315200, 13315217, 13320585, 13320594, 13329232, 13329248, 13332167, 13334774, 13334775, 13342868, 13349026, 13352485, 13366188, 13366191, 13366194, 13366195, 13366196, 13369415, 13369426, 13380379, 13382712, 13391138, 13391139, 13396128, 13404831, 13404832, 13416497, 13420104, 13420105, 13281802X, NS13315219, NS13315220, NS13329249, NS13334773, NS13349037, NS13352484, NS13352486, NS13401845, NS13426336, 13143101, 13150445, 13159707, 13159715, 13166166, 13168195, 13186332, 13186337, 13214441, 13217127, 13221797, 13223835, 13229666, 13237660, 13246546, 13249446, 13262327, 13265329, 13291866, 13294513, 13307179, 13318024, 13332149, 13332159, 13337780, 13337796, 13346086, 13352434, 13352441, 13354252, 13366190, 13366197, 13382711, 13396125, 13398833, 13398835, 13413758, 13420106, 13205314, 13205322, 13229673, 13229685, 13234800, 13249450, 13256702, 13262338, 13265332, 13265337, 13279097, 13288121, 13291877, 13297249, 13297260, 13297261, 13301872, 13310761, 13312706, 13318040, 13318062, 13332170, 13346105, 13349029, 13354271, 13354272, 13357259, 13360427, 13360442, 13366230, 13372465, 13372469, 13375211, 13375227, 13377002, 13391151, 13398856, 13426338, 13329254X, 13332169X, 13342871X, 13192055, 13192067, 13200423, 13200424, 13202961, 13202963, 13205309, 13205315, 13205323, 13205324, 13223833, 13229686, 13229687, 13231803, 13234792, 13234801, 13237654, 13243208, 13243209, 13246544, 13246548, 13249451, 13249452, 13249453, 13254617, 13254618, 13262329, 13262330, 13279085, 13281530, 13281531, 13281790, 13281791, 13286645, 13286646, 13286647, 13286648, 13286650, 13286651, 13286652, 13303358, 13303361, 13303362, 13303366, 13303367, 13303368, 13303371, 13303372, 13303373, 13303374, 13303375, 13306335, 13306336, 13319484, 13319489, 13319495, 13346087, 13349006, 13352444, 13354260, 13354261, 13354262, 13357229, 13357230, 13360411, 13360412, 13360413, 13363220, 13363221, 13366231, 13366232, 13372470, 13372491, 13380384, 13382718, 13388328, 13391161, 13398857, 13401849, 13435154, 13438159, 13449366, 13449367, 13455464, 13279081X, 13197465, 13203168, 13203169, 13205344, 13205348, 13229675, 13229688, 13265333, 13268039, 13281806, 13310762, 13318041, 13329229, 13329233, 13342873, 13349039, 13354264, 13357260, 13372472, 13398839, 13441228, NS13186257, NS13186258, NS13246550, NS13260027, NS13304448, NS13329255, NS13329256, NS13333102, NS13354273, NS13354274, NS13360443, NS13360444, NS13388330, NS13401851, 13189185, 13194984, 13202958, 13205307, 13207466, 13207473, 13231809, 13234793, 13249454, 13262331, 13268033, 13288117, 13303369, 13303376, 13315174, 13332151, 13337783, 13337797, 13346088, 13346089, 13357215, 13357232, 13360414, 13366236, 13377003, 13401855, NS13357214, NS13366235, 13135874, 13141336, 13162743, 13168158, 13192089, 13214454, 13229690, 13237656, 13265339, 13297262, 13312708, 13320587, 13323491, 13342872, 13349041, 13363230, 13382710, 13407498, NS13140914, NS13219558, NS13221811, NS13246568, NS13265338, NS13291878, NS13291879, NS13312707, NS13342874, NS13349040, NS13360428, NS13372495, 13105055, 13124400, 13124401, 13135880, 13138926, 13140911, 13141335, 13162741, 13162742, 13168155, 13168156, 13170665, 13189283, 13214450, 13214451, 13214452, 13214455, 13221812, 13231810, 13237657, 13249434, 13252354, 13252362, 13262332, 13288118, 13291868, 13294511, 13307182, 13315176, 13337784, 13337785, 13337786, 13346090, 13354241, 13357216, 13360416, 13366208, 13366240, 13380385, 13388332, 13297248, 13318063, 13320595, 13334764, 13388304, 13435140, 13291880X, NS13246556, NS13265340, NS13288123, 13229667, 13231805, 13254613, 13291858, 13291869, 13310725, 13318020, 13337787, 13337798, 13346070, 13354237, 13366209, 13369431, 13375208, 13391162, 13407499, 13435157, NS13401856

• Flexor Tuohy-Borst Side-Arm Introducers (Shuttle Select)
  • Catalog numbers: DYB, KSAW-5.0-38-90-RB-SHTL-FLEX-HC, KSAW-6.0-38-90-RB-SHTL-FLEX-HC
  • Lot Numbers: 13029776, 13050652, 13082600, 13082601, 13082603, 13101307, 13101310, 13131722, 13141048, 13141049, 13150557, 13155318, 13155322, 13179880, 13186371, 13186372, 13192133, 13211850, 13237759, 13274344, 10332622, 10332623, 10335453, 10335456, 10338048, 10338049, 10338050, 10342579, 10342580, 10342581, 10342582, 10342590, 13002891, 13002897, 13006165, 13006166, 13006181, 13008773, 13008784, 13008785, 13008786, 13008787, 13011537, 13011538, 13014541, 13014545, 13020497, 13020498, 13020511, 13023868, 13023878, 13023879, 13029745, 13029746, 13029747, 13029748, 13029749, 13029750, 13029751, 13035275, 13039774, 13043788, 13043802, 13043803, 13043804, 13043805, 13043806, 13043807, 13047789, 13047790, 13050311, 13050324, 13050325, 13086346, 13086347, 13086348, 13089656, 13089657, 13094405, 13097678, 13097679, 13097681, 13097691, 13097692, 13101233, 13105097, 13105098, 13105099, 13105100, 13105101, 13126489, 13126490, 13126491, 13128737, 13128738, 13134895, 13134897, 13141007, 13141008, 13141009, 13141010, 13143117, 13143120, 13143121, 13143129, 13143130, 13143131, 13178615, 13178617, 13186365, 13186366, 13189358, 13192148, 13192149, 13195043, 13197524, 13197525, 13197526, 13197533, 13200500, 13205399, 13205415, 13205416, 13205417, 13205418, 13207558, 13207586, 13219603, 13221896, 13221903, 13223326, 13223327, 13223328, 13223329, 13223330, 13223331, 13223332, 13223333, 13226894, 13229771, 13229772, 13231878, 13231879, 13234846, 13234847, 13237736, 13240039, 13240048, 13240066, 13246623, 13246624, 13246625, 13249506, 13249507, 13249508, 13254754, 13260085, 13268159, 13274346, 13274363, 13274364, 13274365, 13276219, 13276220, 13276221, 13276222, 13279330, 13281720, 13281732, 13281733, 13284579, 13284580, 13284581, 13284582, 13284583, 13288184, 13288185, 13292062, 13294665, 13312741, 13312742, 13312750, 13315287, 13315288, 13315289, 13318101, 13318109, 13320658, 13320659, 13320660, 13320661, 13323519, 13323520, 13323521, 13323546, 13327092, 13327093, 13329060, 13329061, 13332072, 13332073, 13346140, 13346160, 13346161, 13346162, 13349095, 13349100, 13349125, 13352236, 13352237, 13352238, 13352239, 13352240, 13354220, 13363114, 13363115, 13363140, 13363141, 13363142, 13410269, 13458470, 13458471