Events

Recall of Device Recall Stingray Catheter

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

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
    62450
  • Event Risk Class
    Class 2
  • Event Number
    Z-2074-2012
  • Event Initiated Date
    2012-06-26
  • Event Date Posted
    2012-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110688
  • 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
    Bridgepoint medical inc. is voluntarily recalling stingray catheter, model m1000 lots bp20121440078 and bp20121560089. bridgepoint medical, inc. recently determined the potential of compromised sterility assurance of the product due to a faulty pouch seal. in no case was there any reported adverse clinical event related to the problem.
  • Action
    The firm, BridgePoint Medical, sent an "Urgent Field Safety Notice" letter dated June 26, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory, quarantine the affected lots and complete and return the enclosed "Verification Form" via fax to 763-225-8718 ,attn: BridgePoint Medical, Inc., Upon receipt of form, BridgePoint will supply the customers with the appropriate materials to return the products. If you have any questions regarding this notice, please call BridgePoint Medical, Vice President of Quality Assurance, at 763-225-8511 or e-mail at cschlawin@bridgepointmedical.com.

Device

Device Recall Stingray Catheter
  • Model / Serial
    Lots affected in US: BP20121440078, BP20121560089 Lots affected OUS: BP20121510086, BP20121500080
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including: AL, AZ, CA, CO, GA, IL, KY, MD, MN, MO, NC, NY, OR, PA, WA, and WI; and countries of: Australia and Sweden.
  • Product Description
    BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medical Inc. 13355 10th Ave N, Suite 110, Plymouth, MN 55441. || Stingray" Catheters are intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) prior to PTCA or stent intervention. When used as part of the BridgePoint Medical System, the Stingray Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention. .
  • Manufacturer
    Bridgepoint Medical

Manufacturer

Bridgepoint Medical
  • Manufacturer Address
    Bridgepoint Medical, 13355 10th Ave N, Suite #110, Minneapolis MN 55441-5553
  • Source
    USFDA