Events

Recall of Device Recall RF Ablation System Foot Switch

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
    50483
  • Event Risk Class
    Class 2
  • Event Number
    Z-0858-2009
  • Event Initiated Date
    2008-11-25
  • Event Date Posted
    2009-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75468
  • 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
    Cardiac Ablation Percutaneous Catheter - Product Code LPB
  • Reason
    Product malfunction may result in delivery of energy without depressing the foot switch that controls delivery.
  • Action
    Recall initiated on November 25, 2008. Urgent Company Initiated Medical Device Recall - Immediate Action Required letters, dated 11/26/2008, were sent to consignees via Federal Express and included return and reply forms for consignees to respond. The letters asked that further distribution or use of any foot switch affected by this recall be ceased immediately. Attached to the letter was a document entitled "Instructions for Determining Affected Product," which provided instructions and serial numbers for determining if customers have product affected by this recall. In addition, a document entitled "Recall Instructions" was also attached. Affected product should be segregated and returned to Boston Scientific in accordance to the "Recall Instructions," and the Reply and Verification Tracking Form should be completed and returned. Customers will receive replacement product for all recalled product returned to Boston Scientific. Local Sales Reps should be contacted in regards to any questions customers may have pertaining to this recall.

Device

Device Recall RF Ablation System Foot Switch
  • Model / Serial
    M004 218400, Serial numbers starting in 0430200, 0530100, 0606100, 0610000, 0620200, 0623700, 0626500, 0629900, 0634800, and ending in 001-405.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of France, Great Britain, Saudi Arabia, Spain, Canada, Portugal, Germany, Italy, Australia, Russia, Netherlands, Ireland, Libya.
  • Product Description
    RF Ablation System Foot Switch. (Can be used with Boston Scientific Maestro 3000 and EPT-1000XP Cardiac Ablation Cardiac Ablation Systems). Manufactured by Altech Corporation, Flemmington NJ and distributed by Boston Scientific Corporation, San Jose, CA, catalog numbers/UPN numbers 21840/M004 218400. || Indicated for use in cardiac ablation procedures.
  • 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