Events

Recall of Device Recall Percutaneous Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vascular Solutions, 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
    64215
  • Event Risk Class
    Class 2
  • Event Number
    Z-0868-2013
  • Event Initiated Date
    2013-01-29
  • Event Date Posted
    2013-02-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115591
  • 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
    Catheter, percutaneous - Product Code DQY
  • Reason
    Vascular solutions, inc has discovered a potential problem with a number of lots of supercross microcatheters. a potential for surface contamination on aged catheters was observed during in-house testing.
  • Action
    Vascular Solutions sent an "Urgent Medical device Recall" letter dated January 28, 29013 to all affected customers. The letter identified the affected product, described the problem and actions to be taken. The letter advised customers to remove the product from their inventory and to complete and return the VSI Account Inventory Form. For questions contact your local Sales Representative.

Device

Device Recall Percutaneous Catheter
  • Model / Serial
    559450, 551750, 552370, 552761, 552840, 552954, 553267, 553647, 553931, 554269, 554270, 554413. 555958, 557192, 557824, 558222, 558894, 559827, 560215, 551751, 552371, 552841, 553090, 553218, 553434, 553529, 554029,  554268, 554271, 555759, 555953, 557251, 559570, 559981, 560253, 560079,  560080, 554123, 556182, 558905, 560114, 554210, 555991, 556842, 557253, 554209, 555223, 555992, 556536, 556747, 557124, 558327, 558991, 560115, 561206, 554208, 555490, 555993, 556674, 556843, 558018, 558798, 559707, 560433, 561207, 554040, 555007, 555224, 555358, 558542, 560434, 561459, 554122, 555008, 555225, 555994, 558992, 561208, 560221, 560222, 560223, 560995, 560996.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide including the states of AL, AZ, AR, CA, CO, CT, DE, CD, FL, GA, HI, ID, IL ,IN, IA, KY, LA, ME, MD, MA, MI,MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT VA, WA, WV, WI, WY and AUSTRIA, CANDA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, ISRAEL,. ITALY, MEXICO, NETHERLANDS, NORWAY, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED KINGDOM.
  • Product Description
    Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324, 5325, 5329, 5332, 5336, 5340, and 5341. || Product Usage: || The SuperCross catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents
  • Manufacturer
    Vascular Solutions, Inc.

Manufacturer

Vascular Solutions, Inc.
  • Manufacturer Address
    Vascular Solutions, Inc., 6464 Sycamore Ct N, Maple Grove MN 55369-6032
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA