Events

Recall of Device Recall Mach 1 Guide Catheter 6F, IM Internal Mammary 90cm, .070 in

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
    46785
  • Event Risk Class
    Class 3
  • Event Number
    Z-1300-2008
  • Event Initiated Date
    2008-02-07
  • Event Date Posted
    2008-05-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68264
  • 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
    Mislabeled: seven lots/ batches of boston scientific mach 1 guide catheter may be mislabeled with the incorrect device length.
  • Action
    Consignees were sent a Boston Scientific Urgent Voluntary Medical Device Recall letter on 2/7/08. The letter included the customer steps for recall, a complete listing of all product batches being recalled, the Reply Verification Tracking Form(s) and a return shipping label.

Device

Device Recall Mach 1 Guide Catheter 6F, IM Internal Mammary 90cm, .070 in
  • Model / Serial
    Lot Number: 20022689
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA states of PA, AZ, NY, KY, CA, WV, OH, WA, MI, TN, IN, IL, NJ, KY, FL, AR, FL, NC, CO, TX, WV, WI, OR, AL, MN and ND and countries of BE, FR, GB, DE, IE, IT, JP, AU, SOUTH KOREA, NZ, TR, TW and ZA.
  • Product Description
    Boston Scientific Mach 1 Guide Catheter 6F, IM Internal Mammary 90cm, .070 in (internal dia), shaft lenght, 90 cm, Catalon Number: 34356-446, UPN H749343564460, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, One Boston Scientific Place, Natick MA 01760
  • Source
    USFDA