Events

Recall of Device Recall VASCUGUARD Pheripheral Vascular Patch

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synovis Surgical Innovations, 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
    71191
  • Event Risk Class
    Class 1
  • Event Number
    Z-1637-2015
  • Event Initiated Date
    2015-05-02
  • Event Date Posted
    2015-05-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136433
  • 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
    Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
  • Reason
    Baxter healthcare is recalling specific product codes of vascu-guard peripheral vascular patch due to complaints received for difficulty in distinguishing the smooth from rough surface.
  • Action
    The firm, Baxter, sent an "Urgent Product Recall" letter dated 5/2/2015 via USPS overnight delivery to its customers. The letter identified the affected product, problem and actions to be taken. The customers were instructed to immediately discontinue use and segregate the affected product, locate and remove all affected product from your facility and to return it to Baxter. Customers are to contact Baxter Healthcare Center, 888-229-0001, for Service to arrange for return and credit. In addition, the customers were to complete and return the Customer Reply Form by faxing to 224-270-5457 or emailing to fca@baxter.com. If you have any questions, contact Director, Quality at 651-796-7543 or email: heidi_drafall@baxter.com.

Device

Device Recall VASCUGUARD Pheripheral Vascular Patch
  • Model / Serial
    all lot numbers
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile. VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
  • Manufacturer
    Synovis Surgical Innovations, Inc.

Manufacturer

Synovis Surgical Innovations, Inc.
  • Manufacturer Address
    Synovis Surgical Innovations, Inc., 2575 University Ave W, Saint Paul MN 55114-1073
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA