Events

Recall of Device Recall SICD Programmer

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
    76323
  • Event Risk Class
    Class 2
  • Event Number
    Z-1178-2017
  • Event Initiated Date
    2017-01-12
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152779
  • 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
    Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
  • Reason
    There is a potential for radio frequency (rf) interference to alter wireless communication from a programmer, which in rare instances may cause an s-icd to perform an unintended command. this behavior can only occur during an active, in-clinic interrogation/programming session with the model 3200 s-icd programmer. there is no risk of this behavior occurring when the latitude patient management system communicates with an s-icd in an ambulatory setting.
  • Action
    Boston Scientific sent an "Important Medical Device Information" letter dated on January 12, 2017. The letter was addressed to "Dear Doctor". The letter included information on the Description and Clinical Implications, Rate of Occurrence, Recommendations, Affected Programmer & Additional Information. For additional questions regarding this communication or to report clinical events, contact your Boston Scientific representative or Technical Services at 1 800-227-3422.

Device

Device Recall SICD Programmer
  • Model / Serial
    All serial numbers.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA ( nationwide) including PR and to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY., and to the countries of :Canada, Austria, Belgium, Czech Republic, Denmark, Finland, France, French Polynesia, Guadeloupe, Monaco, New Caledonia, Reunion, Germany, Greece, Hungary, Ireland, Israel, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, United Kingdom, Australia, China, Egypt, Hong Kong, India, Iran, Japan, Jordan, Kuwait, Lebanon, Malaysia, New Zealand, Qatar, Saudi Arabia, Singapore, South Africa, Thailand, Tunisia, Turkey, United Arab Emirates, Argentina, Bermuda and Brazil.
  • Product Description
    Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • 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