Events

Recall of Device Recall IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm)

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

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
    68373
  • Event Risk Class
    Class 2
  • Event Number
    Z-1795-2014
  • Event Initiated Date
    2014-05-15
  • Event Date Posted
    2014-06-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127482
  • 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
    Some units of intella tip mifi xp temperature ablation catheters were not manufactured according to specification.
  • Action
    Customers were informed of the recall via overnight letter sent on May 15, 2014.

Device

Device Recall IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm)
  • Model / Serial
    Catalog Number: PM4500K2; Material Number: M004PM45000K20; Serial numbers: 16560406, 16560408, 16573562, 16573563, 16573564, 16599366, 16606148, 16615974, 16615975, 16623756, 16743274, 16743275, 16743276, 16757632, 16757633, 16757634, 16757635, 16757636, 16757637, 16757638, 16757639, 16757781, 16757782, 16872835. Expiry Dates: May 11, 2014 to January 13, 2017
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. || The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 47215 Lakeview Blvd, Fremont CA 94538-6530
  • 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