Devices

Device Recall Neuro Renegade HiFlo Microcatheter

  • Modelo / Serial
    Lots:  11249879, 11542408, 11750295, 11966695, 12156146, 12228393, 12365497, 12491154,  11253574, 11546053, 11756331, 11988066, 12156147, 12228443, 12365604, 12509751,  11257185, 11552115, 11776786, 11996448, 12156183, 12228444, 12365605, 12509758,  11268801, 11554501, 11793108, 12001306, 12170507, 12248055, 12365613, 12509920,  11271408, 11559603, 11800162, 12001562, 12170508, 12248109, 12365614, 12527317,   11562655,  11274973, 11572313, 11806766, 12001567, 12170516, 12248121, 12385142, 12527760,  11296064, 11573180, 11819657, 12001568, 12175704, 12262088, 12385143, 12527763,  11301389, 11577242, 11825864, 12021328, 12175706, 12270709, 12385158, 12527769,  11303513, 11580376, 11836834, 12028753, 12175708, 12270714, 12385224, 12546795,   11840079,  11307943, 11586443, 11843094, 12039033, 12175710, 12270983, 12402095, 12546199,  11318319, 11587960, 11849818, 12049925, 12175711, 12279662, 12402111, 12546941,  11319596, 11602048, 11857667, 12061129, 12175713, 12292373, 12421265, 12546946,  11423369, 11623809, 11869009 12068930, 12175717, 12296121, 12421267, 12560791,   12073876,  11425310, 11627605, 11876193, 12089556, 12175719, 12296833, 12421271, 12560192  11425314, 11631734, 11880345, 12104631, 12175724, 12297455, 12421274, 12578834  11429065, 11638177, 11884227, 12104678, 12194075, 12311446, 12439946, 12578835  11429069, 11649446, 11891449, 12108064, 12194077, 12311459, 12439951, 12578864   12194829,  11432583, 11656601, 11891458, 12120518, 12194831, 12311520, 12439954, 12614498,  11432584, 11678955, 11895180, 12120528, 12214586, 12326062, 12439958, 12634309,  11441965, 11682874, 11895183, 12123141, 12214589, 12330440, 12458414, 12634310,  11444027, 11695922, 11925162, 12133525, 12214592, 12330441, 12458475, 12634315,   12330443,  11445708, 11703970, 11927490, 12142142, 12214602, 12330465, 12458416, 12659579,  11461698, 11706368, 11933896, 12142150, 12214604, 12330476, 12458543, 12660000,  11469070, 11710717, 11941913, 12148683, 12214616, 12330511, 12458548,  11481564, 11714291, 11948975, 12148684, 12228116, 12348609, 12466721,  11534917, 11721375, 11959863, 12148687, 12228366, 12365495, 12466123,
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution Worldwide, including throughout the US.
  • Descripción del producto
    Boston Scientific brand Neuro Renegade Hi-Flo Microcatheter, 150cm/20cm; Rx Only; || Model Numbers: 182880US, 182890US, 182900US, 182910US; Product is distributed by || Boston Scientific Corporation, Natick, MA; || Product is manufactured by Boston Scientific Corporation, Cork, Ireland
  • Manufacturer
    Boston Scientific Corporation
  • 1 Event

Fabricante

Boston Scientific Corporation
  • Dirección del fabricante
    Boston Scientific Corporation, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA