Events

Recall of Device Recall Gelweave (TM) Vascular Prostheses

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

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
    68952
  • Event Risk Class
    Class 2
  • Event Number
    Z-2266-2014
  • Event Initiated Date
    2014-07-15
  • Event Date Posted
    2014-08-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129138
  • 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
    Prosthesis, vascular graft, of 6mm and greater diameter - Product Code DSY
  • Reason
    The cautery that is provided with the gelweave graft in the box has a shorter shelf life indicated on its label, versus that of the graft (4 years and 5 years, respectively).
  • Action
    Vascutek sent an Urgent Field Safety Notice dated July 15, 2014, to all affect customers. The letter identified the product the problem and the action needed to be taken by the customer. User Instructions: A. Vascutek advises that you ensure suitable equipment is available prior to implantation to trim the graft if required. B. For product received with a cautery in the interim, Vascutek request that you check the shelf life of each product before every operation. If you find that the cautery is out of date, remove and discard the cautery. If you require an appropriate cautery supplied as a separate item, please contact your local sales representative for a referral. C.Vascutek are taking this opportunity to reinforce the cautions from the Gelweave TM Vascular Prostheses IFU regarding soaking of the graft in saline to prevent focal burning if a cautery is to be used. This statement is already included in the IFU and now appears in bold, red font to ensure appropriate awareness. This notice needs to be passed on to all persons who need to be aware within your organization or to any organization where the devices have been transferred or distributed. Please maintain awareness of this Field Safety Notice while all actions are taken in your organization and until these products are provided without the cautery. Please return the User Return Slip by e-mail or fax to the Distributor's address given on page 3. This action by Vascutek Ltd. is being taken with the knowledge of the National Competent Authority¿ Medicines and Healthcare Products Regulatory Agency (MHRA). If you have any further questions or comments, please do not hesitate to contact us at tcvs.recall@terumomedical.com. Return Completed Form immediately fax to (734) 741-6149. If required, your Vascutek Ltd. representative can discuss and provide more information on the use of cautery with Vascutek products. For further questions call (800) 262-3304 ext. 6056

Device

Device Recall Gelweave (TM) Vascular Prostheses
  • Model / Serial
    731030, 731032, 731034, 731036,731038, 731206, 731218, 731220, 731222, 731224, 731226, 731228, 731407, 731506, 731507, 731508, 731509, 731510, 731512, 731514, 731516, 731608, 731809, 732010, 732030, 732032, 732034, 732038, 732211, 732412, 732518, 732520, 732522, 732524, 732526, 732528, 733006, 733007, 733008, 733010, 733012, 733014, 733016, 733018, 733020, 733022, 733024, 733026, 733028, 733030, 733032, 733034, 733036, 733038, 733040, 733042, 734030, 734032, 734034, 734036, 734038, 735018, 735020, 735022, 735024, 735026, 735028, 736006, 736007, 736008, 736010, 736012, 736014, 736016, 736018, 736020, 736022, 736024, 736026, 736028, 736030, 736032, 736034, 736036, 736038, 731206/10/10, 731206/10/10RM, 731206/7, 731407/10/10, 731407/10/10RM, 731407/6X2RM, 731407/7, 731608/10/10, 731608/10/10RM, 731608/6, 731608/7, 731608/7X2RM, 731608/8/10, 731608/8/10RM, 731809/6, 732010/6, 732412/6, 7330303BL, 7330323BL, 7330343BL, 7330363BL, 7330383BL
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including the states of : AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WV.
  • Product Description
    Gelweave (TM) Vascular Prostheses || Manufactured by - VASCUTEK Ltd || a TERUMO company
  • Manufacturer
    Vascutek, Ltd.

Manufacturer

Vascutek, Ltd.
  • Manufacturer Address
    Vascutek, Ltd., Newmains Avenue, Inchinnan United Kingdom
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA