Events

Recall of Boston Scientific brand Matrix2 Firm 2D 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-0858-2011
  • 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=96010
  • 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 Firm 2D Coils.
  • Model / Serial
    Material Product Description Catalog # Batch Numbers Expiry Date   M003480 1030 Matrix2¿ Firm 2D 10mm X 30cm 4801030 11253687,11766663 Oct2010 through   10mm X 30cm May2011  M0034801230 Matrix2¿ Firm 2D 12mm X 30cm 4801230 11766667,12707248 May2011 through   12mm X 30cm May2012  M0034801430 Matrix2¿ Firm 2D 14mm X 30cm 4801430 11697099 Apr2011   14mm X 30cm  M0034801630 Matrix2¿ Firm 20 16mm X 30cm 480163 11426183,11766662 Dec2010 through   16mm X 30cm May2011  M0034801830 Matrix2¿ Firm 20 18mm X 30cm 4801830 11411206 Dec2010   18mm X 30cm  M0034802030 Matrix2¿ Firm 20 20mm X 30cm 480203 11777398 May2011   20mm X 30cm  M0034805150 Matrix2¿ Firm 20 5mm X 15cm 480515 11777399 May2011   5mm X 15cm  M0034806150 Matrix2¿ Firm 20 6mm X 15cm 480615 11757096 Apr2011   6mm X 15cm  M0034807200 Matrix2¿ Firm 20 7mm X 20cm 480720 11748387,12365836 Apr2011 through   7mm X20cm Jan2012  M0034808300 Matrix2¿ Firm 20 8mm X 30cm 480830 11297219,11991894,12365835 Oct2010 through   8mm X30cm Jan2012  M0034809300 Matrix2¿ Firm 20 9mm X 30cm 480930 11411626,11622081,12365834 Dec2010 through   9mm X30cm 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 Firm 2D 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