Events

Recall of Device Recall Mach 1 Guide Catheter

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
    37001
  • Event Risk Class
    Class 2
  • Event Number
    Z-0384-2007
  • Event Initiated Date
    2006-12-13
  • Event Date Posted
    2007-02-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49746
  • 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 guide catheter - Product Code DQY
  • Reason
    Excess strands of resin may exist in the lumen near the hub of certain batches/lots of the mach 1 guide catheters. if this excess resin is present in the catheter, there is the potential of an embolization resulting from the excess resin detaching from the device during the procedure.
  • Action
    An Urgent Medical Device Recall letter, dated 12/13/06, and a Clarification of Recall Notification letter, dated 12/14/06, were sent to all affected hospitals. The letter describes the issue, affected product, asks for customers to discontinue further distribution or use of any remaining product and asks for product to be returned. Replacement product will be available for any/all returned product.

Device

Device Recall Mach 1 Guide Catheter
  • Model / Serial
    Batch / Lot # 687654
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Boston Scientific Mach 1 Guide Catheter Femoral Approach, 7F, 0.081'', Multipurpose Curve, UPN # H74934357380, Catalog # 34357-38. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tijuana, Baja California 22650 MEX.
  • Manufacturer
    Boston Scientific

Manufacturer

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