Events

Recall of Boston Scientific brand Matrix2 360 Firm Coils.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538.

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
    57179
  • Event Risk Class
    Class 2
  • Event Number
    Z-0861-2011
  • Event Initiated Date
    2010-10-19
  • Event Date Posted
    2011-01-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96013
  • 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
    vascular embolization device - Product Code HGC
  • Reason
    The product appears to have premature degradation of the pgla coating on the matrix coil.
  • Action
    US consignees were notified by letter sent by Federal Express on October 19, 2010. Customers out of the United States were notified by Federal Express if possible and by personal delivery by locally assigned sales representatives as needed.

Device

Boston Scientific brand Matrix2 360 Firm Coils.
  • Model / Serial
    Material Product Description Catalog # Batch numbers Expiry Date    Matrix2¿ 360 Firm Coils 1 Omm x 11252548,11403351,11513899,11552537, Oct2010 through  M0034941 030 494103 11640881,12009568,12102561,12229607,   30cm 12365838, 12366382 Jan2012  M0034941230 Matrix2¿ 360 Firm Coils 12mm x 494123 11560338,11766417,11782395,11925586, Feb2011 through   30cm 12026743, 12316656, 12636596 Apr2012   11244766,11336915,11456769,11484774,  M0034941430 Matrix2¿ 360 Firm Coils 14mm x 494143 11526777, 11766660, 11850791, 11958233, Oct2010 through   30cm 11958454,12317003,12396265,12753164, Jan2013   13165081,13182077,13230095   11253266,11336717,11454608,11489048,  M0034941630 Matrix2¿ 360 Firm Coils 16mm x 494163 11526778,11697444,11697471,11958444, Oct2010 through   30cm 12176133,12214864,12319343,12396264, Dec2012   12859706, 13194482   11385269,11389724,11454839,11498643,  M0034941 830 Matrix2¿ 360 Firm Coils 18mm x 494183 11609723,11766661,11869780,11958440, Dec2010 through   30cm 12036898,12225706,12316657,12365837, Aug2012   12396263, 12854017, 12929266   Matrix2¿ 360 Firm Coils 20mm x 11330476,11483884,11526779,11697442, Nov2010 through  M0034942030 494203 11766414,11766673,11958234,11999799,   30cm 12194742,12317006,12753163,12859707 Jul2012   11252232,11380482,11551322,11785187,   11785188,11785190,11785191,11785192,  M0034942440 Matrix2¿ 360 Firm Coils 24mm x 494244 11785193,11785194,11785195,11813607, Oct2010 through   40cm 11813608,11813609,11813610,11850841, Jul2012   12176108,12316654,12395388,12395420,   12428559,12429040,12841941,12861721  M0034945150 Matrix2¿ 360 Firm Coils 5mm x 494515 12214867,12636725 Oct2011 through   15cm Apr2012  M00349461 50 Matrix2¿ 360 Firm Coils 6mm x 494615 11340651,11474492,11958445 Nov2010 through   15cm Jul2011  M0034947200 Matrix2¿ 360 Firm Coils 7mm x 494720 11338767,11697459 Nov2010 through   20cm Apr2011  M0034948300 Matrix2¿ 360 Firm Coils 8mm x 494830 11488191,11850853,12000340 Jan2011 through   30cm Aug2011  M0034949300 Matrix2¿ 360 Firm Coils 9mm x 494930 11327025,11697448,11838298,11958230, Nov2010 through   30cm 12365839,12367860 Jan2012
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. USA, Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Serbia, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, India, Israel, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Macau, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Taiwan, Turkey, Ukraine, Vietnam, and Yemen.
  • Product Description
    Boston Scientific brand Matrix2 360 Firm Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.
  • Manufacturer
    Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538

Manufacturer

Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538
  • Manufacturer Address
    Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538, 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