Events

Recall of FIRMap 60mm Catheter

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

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
    71970
  • Event Risk Class
    Class 3
  • Event Number
    Z-2478-2015
  • Event Initiated Date
    2015-08-12
  • Event Date Posted
    2015-08-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139471
  • 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,intracardiac mapping,high-density array - Product Code MTD
  • Reason
    The expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to customer sites. the manufacturing date was accidentally used (copied) for the expiration date.
  • Action
    The firm, Abbott Electrophysiology, sent an "URGENT PRODUCT RECALL" letter dated August 11, 2015. A customer recall notification letter was distributed to firm representatives who will visit each consignee and inspect inventory for affected product. Letters were provided to reps on August 12, 2015. The letter describes the product, problem and actions to be taken. The customers were informed that the product they have in stock will be return to the firm and will be provided a replacement product free of charge. If you have any questions, contact Quality Director at 650-681-1744.

Device

FIRMap 60mm Catheter
  • Model / Serial
    Model number : USAR064060; Lot code: TPR031615-01
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution in states of: KY, IN, MO, NY, OH, TX, LA, IL, PA, NJ, WA, VA, FL, GA, CT, CA, AZ, CO, and TN.
  • Product Description
    FIRMap 60mm Catheter; || Size: 60 mm; Length 50.4 inches || French Size Diameter: 8.5F (2.84mm) || Model number : USAR064060 || Sterile, Rx only || Cardiovascular: For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
  • Manufacturer
    Abbott Electrophysiology

Manufacturer

Abbott Electrophysiology
  • Manufacturer Address
    Abbott Electrophysiology, 1530 Obrien Dr, Menlo Park CA 94025-1454
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA