Events

Recall of Device Recall Renegade Fiber Braided Microcatheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53048
  • Event Risk Class
    Class 2
  • Event Number
    Z-0358-2011
  • Event Initiated Date
    2009-08-24
  • Event Date Posted
    2010-11-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84540
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, continuous flush - Product Code KRA
  • Reason
    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.
  • 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.

Device

Device Recall Renegade Fiber Braided Microcatheter
  • Model / 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,
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution Worldwide, including throughout the US.
  • Product Description
    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
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “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