—#84540

Product

Boston Scientific brand Renegade Fiber Braided Microcatheter, 150/10/2RO, Rx Only; Model Numbers: 18257, 18259; Product is distributed by Boston Scientific Corporation, Natick, MA; Product is manufactured by Boston Scientific Corporation, Cork, Ireland

FDA product code: KRA — Catheter, Continuous Flush
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K973645
Affected lot / code info: 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,

Why it was recalled

Sterility Loss-- The sterile barrier pouch seal (top seal) may be breached by the product, resulting in loss of sterility which may result in transmission of disease or infection.

Root cause (FDA determination)

Packaging process control

Action the firm took

Boston Scientific issued an Urgent Medical Device Recall letter dated August 26, 2009 identifying the affected devices, the issue prompting the recall, and actions to be taken by customers. Customers were instructed to determine if they have affected product in their inventory, and if so, immediately quarantine and return to Boston Scientific. Customers can contact Boston Scientific at 510 624-1734.

Recalling firm

Firm: Boston Scientific Corporation
Address: 47900 Bayside Pkwy, Fremont, California 94538-6515

Distribution

Distribution pattern: Distribution Worldwide, including throughout the US.

Timeline

Recall initiated: 2009-08-24
Posted by FDA: 2010-11-15
Terminated: 2011-02-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #84540. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.