Events

Recall of AngioSeal Evolution

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

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
    80242
  • Event Risk Class
    Class 2
  • Event Number
    Z-2337-2018
  • Event Initiated Date
    2018-04-09
  • 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=164942
  • 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
    Device, hemostasis, vascular - Product Code MGB
  • Reason
    Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. although sterile, products from these lots may not function as intended and therefore should not be used.
  • Action
    On April 9, 2018, the firm sent Urgent Voluntary Medical Device Recall letters and Inventory Confirmation Forms to customers via FedEx. The letter described the product issue. Customers were asked to: 1. Review your Angio-Seal Evolution inventory immediately to identify and isolate affected inventory in order to prevent future use. 2. Your Terumo Territory Manager will visit your facility to confirm product inventory and assist you in completing the enclosed Recall Acknowledgement/ Inventory Confirmation Form. This required documentation, along with the enclosed Fed-Ex product shipment labels will facilitate your return of affected Angio-Seal Evolution product to Terumo Medical Corporation.

Device

AngioSeal Evolution
  • Model / Serial
    5980075, 5980077
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Distributed to accounts in AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, and TX.
  • Product Description
    Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
  • Manufacturer
    Terumo Medical Corp

Manufacturer

Terumo Medical Corp
  • Manufacturer Address
    Terumo Medical Corp, 2101 Cottontail Ln, Somerset NJ 08873-1277
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA