Events

Recall of Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58

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

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
    66561
  • Event Risk Class
    Class 2
  • Event Number
    Z-0378-2014
  • Event Initiated Date
    2013-10-10
  • Event Date Posted
    2013-11-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122612
  • 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
    Clip, aneurysm - Product Code HCH
  • Reason
    Specific item numbers form lots 27-j and 29-j of sugita t2 aneurysm clips. mini temporary type, are discolored.
  • Action
    Mizuho sent a Product Recall Notice dated October 10, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to verify serial number before opening package and conduct a physical examination of the product for discolored Clips from the affected lots. Customers were also asked to fill out the Confirmation of User Receipt, and return to Misuho America. If customers should find affed clips they were instructed to quarantine them an call Mizuho America Customer Service at 800-699-2547 for return instructions. The Clips will be exchanged at no charge. Customers were also asked to ensure that all appropriate persons within the Hospital have been notified of the Recall Notice. For questions regarding this recall call 510-324-4500, ext 122.

Device

Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58
  • Model / Serial
    Product Code 17-001-58; Lot No. 29JY
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 || Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.
  • Manufacturer
    Mizuho America, Inc.

Manufacturer

Mizuho America, Inc.
  • Manufacturer Address
    Mizuho America, Inc., 30057 Ahern Ave, Union City CA 94587-1234
  • Manufacturer Parent Company (2017)
    Mizuho America Inc.
  • Source
    USFDA