Events

Recall of Device Recall Ultra2 Cutting Balloon

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

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
    35939
  • Event Risk Class
    Class 2
  • Event Number
    Z-1512-06
  • Event Initiated Date
    2006-07-21
  • Event Date Posted
    2006-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47236
  • 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
    Cutting Ballon - Product Code LOX
  • Reason
    Lack of assurance of sterility (pre-sterilization bioburden limits exceeded).
  • Action
    On July 21, 2006, Boston Scientific initiated a voluntary recall of 45 lots/batches of Cutting Balloon Ultra Monorail Devices due to their determination that the lots do not meet their sterilization requirements. There is a remote possibility of infection in the patient. An infection, if it occurred, could be recognized and treated effectively in these patients. Boston Scientific is not aware of any complaints related to this product issue. Letters dated July 21, 2006, were sent to their customers with instructions to cease further distribution, complete and return a tracking form, and product return instructions.

Device

Device Recall Ultra2 Cutting Balloon
  • Model / Serial
    Material Number (UPN) / Catalog Number / Lot/Batch #:  H749CBM200060 / CBM20006 / EG0438 & EG0499;  H749CBM200100 / CBM20010 / EG0427;  H749CBM225060 / CBM22506 / EG0448 & EG0471;  H749CBM225100 / CBM22510 / EG0444 & EG0502;  H749CBM250060 / CBM25006 / EG0439 & EG0472;  H749CBM250100 / CBM25010 / EGO425, EG0440, EG0474 & EG0475;  H749CBM250150 / CBM25015 / EG0466;  H749CBM275060 / CBM27506 / EG0420 & EG0487;  H749CBM275100 / CBM27510 / EG0419 & EG0456;  H749CBM275150 / CBM27515 / EG0424;  H749CBM300060 / CBM30006 / EG0423, EG0473 & EG0497;  H749CBM300100 / CBM30010 / EG0426, EG0441, EG0465, EG0485;  H749CBM300150 / CBM30015 /EG0443 & EG0418;  H749CBM325060 / CBM32506 / EG0500;  H749CBM325100 / CBM32510 / EG0422 & EG0501;  H749CBM325150 / CBM32515 / EG0467;  H749CBM350060 / CBM35006 / EG0437;  H749CBM350100 / CBM35010 / EG0349, EG0428, EG0468;  H749CBM350150 / CBM35015 / EG0421 & EG0486;  H749CBM375060 / CBM37506 / EG0503;  H749CBM375100 / CBM37510 / EG0457;  H749CBM375150 / CBM37515 / EG0455;  H749CBM400060 / CBM40006 / EG0504;  H749CBM400100 / CBM40010 / EG0442 & EG0498;  H749CBM400150 / CBM40015 / EG0476.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Nationwide distribution ---- including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV, and WY.
  • Product Description
    Boston Scientific Cutting Balloon Ultra2 Monorail Device, Boston Scientific, One Boston Scientific Place, Natick, MA 01760.
  • Manufacturer
    Boston Scientific

Manufacturer

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