Events

Recall of Device Recall IntellaTip MiFi XP Asymmetric Curve Temperature Ablation Catheter

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

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
    72721
  • Event Risk Class
    Class 2
  • Event Number
    Z-0463-2016
  • Event Initiated Date
    2015-11-20
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142031
  • 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, cardiac ablation, for treatment of atrial flutter - Product Code OAD
  • Reason
    During routine monitoring of complaints, bsc noted that the intellatip mifi xp n4 complaint rate for distal tip bends/kinks was above the anticipated rate in bscs product risk documentation.
  • Action
    Boston Scientific sent an Urgent Medical Device Removal letters to all affected customers dated November 20, 2015 via Fed Ex or other equivalent service. The letter identified the affected products, problem and actions to be taken. Customers were instructed to contact their local Sales Representative to answer any questions.

Device

Device Recall IntellaTip MiFi XP Asymmetric Curve Temperature Ablation Catheter
  • Model / Serial
    Material Number: M004EPM4790N40;  Catalog number: EPM4790N4; Lot numbers: 16743398, 17135082.. Expiration Date Range: 2/16/2017 to 7/22/2017
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the state of: PA, FL, IN, MI, TN, AL, IL, KY, MI, TX, OH, MO, MA, MN, ID, AL, TN, VA, CA and internationally to Austria, Australia, Belgium, Switzerland, Germany, Great Britain, Greece, Hong Kong, Israel, Iran, Italy, Japan, Kuwait, Latvia, Malaysia, Netherlands, Saudi Arabia, Singapore, Thailand, and South Africa.
  • Product Description
    IntellaTip MiFi XP Asymmetric (N4) Curve || 7/110/2.5/8-10 OUS; || Material Number: M004EPM4790N40; Catalog number: EPM4790N4; || Cardiac: || The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia typically chronic, drug refractory atrial fibrillation.
  • Manufacturer
    Boston Scientific Corp

Manufacturer

Boston Scientific Corp
  • Manufacturer Address
    Boston Scientific Corp, 150 Baytech Dr, San Jose CA 95134-2302
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA