Events

Recall of Boston Scientific Equalizer Balloon Catheter

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
    53471
  • Event Risk Class
    Class 2
  • Event Number
    Z-0195-2010
  • Event Date Posted
    2009-11-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85577
  • 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
    Percutaneous catheter - Product Code DQY
  • Reason
    Boston scientific is initiating a recall removal of numerous batches/lots of equalizer occlusion balloon catheter because the sterile barrier in the packaging of the affected product may be compromised. the outer pouch seal may be breached. if a compromised seal is not detected and a sterility-compromised catheter is used clinically, there is a risk of adverse health consequences.
  • Action
    An Urgent Medical Device Recall Removal letter dated 09/29/2009 was sent to affected facilities and addressed to Risk Manager / Field Action Contact, beginning 09/29/2009. The letter explained the issue and identified product. Customers were asked to identify affected product within their inventory, segregate it and immediately return it to Boston Scientific. Customers will receive replacements for all recalled product that is returned. Customers were also to fax back to Boston Scientific the Reply Verification Tracking Form. Questions regarding this Recall Removal are directed to the local Sales Representative.

Device

Boston Scientific Equalizer Balloon Catheter
  • Model / Serial
    Lot: 11624018, 11624019, 11638187, 11643049, 11643050, 11657067, 11686940, 11712547, 11721526, 11735828, 11740301, 11747702, 11750848, 11785940, 11788316, 11788317, 11803308, 11803309, 11825804, 11825805, 11875441, 11880429, 11884123, 11889229, 11889231, 11892721, 11902172, 11955040, 11960757, 11973983, 11975227, 11975228, 11981135, 11981137, 11992147, 11996765, 12065122, 12065123, 12084934, 12133497, 12133645, 12147787, 12163202, 12163203, 12189809, 12189810, 12189811, 12195813, 12195814, 12215330, 12227668, 12277652, 12280627, 12293199, 12293420, 12293421, 12315905, 12315906, 12315907, 12325752, 12329910, 12347602, 12347604, 12363753, 12397167, 12424299, 12442596, 12459664, 12490330, 12490331, 12494202, 12523132, 12523133, 12523134, 12530895, 12535287, 12535288, 12546340, 12546341, 12546342, 12556161, 12556162, 12567441, 12567442, 12577711, 12577712, 12577713, 12582627, 12617288, 12617289, 12617290, 12622441, 12622442, 12625396, 12625397, 12702153, 12709943, 12709944, 12709945, 12714571, 12720334.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide. US distribution includes: AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Washington D.C. and Puerto Rico. Worldwide distribution includes: Algeria, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Luxembourg, Malaysia, Morocco, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates.
  • Product Description
    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-108 (M001171080). EQL/27/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • 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