Z-0358-2011

Boston Scientific brand Renegade Fiber Braided Microcatheter, 150/10/2RO, Rx Only; Model Numbers: 18257...

Name: Z-0358-2011 Boston Scientific brand Renegade Fiber Braided Microcatheter, 150/10/2RO, Rx Only; Model Numbers: 18257...
Creator: Boston Scientific Corporation
Published: 2009-08-24
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2009-08-24 / Terminated / root cause: packaging

FDA source

Boston Scientific Corporation began a recall of Boston Scientific brand Renegade Fiber Braided Microcatheter, 150/10/2RO, Rx Only; Model Numbers: 18257, 18259; Product is distributed by Boston Scientific... on 2009-08-24. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0358-2011
Status: Terminated
Initiated: 2009-08-24
Posted: 2010-11-15
Terminated: 2011-02-03
Recalling firm: Boston Scientific Corporation
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
Product code: KRA Catheter, Continuous Flush
Reason for recall: 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 tag: packaging
FDA root cause: Packaging process control
Action: 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.
Distribution: Distribution Worldwide, including throughout the US.
Product codes and lots: 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,

Product code KRA

K973645Class IIRenegade Fiber Braided MicrocatheterBoston Scientific Corp / cleared 1997-11-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)