Events

Recall of Device Recall St. Jude Medical

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by St Jude 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
    27045
  • Event Risk Class
    Class 2
  • Event Number
    Z-0052-04
  • Event Initiated Date
    2003-07-31
  • Event Date Posted
    2003-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29066
  • 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
    Implantable Pacemaker Pulse-Generator - Product Code DXY
  • Reason
    Under certain circumstances, pacemaker has a potential to deliver a short coupled pacing interval of approx. 300 msec (200ppm). it is also possible that a patient may experience (up to max of 12) shorter than anticipated pacing intervals.
  • Action
    Sales Representatives will personally contact the physicians, explain the situation, leave a technical memo and a list of implanted patients for the doctor to follow-up with. The ''Dear Doctor'' letter to accompany the representatives is dated 7/31/2003. Instruments not implanted will be returned for reprocessing.

Device

Device Recall St. Jude Medical
  • Model / Serial
    Integrity ADx DR Model 5360 & 5366 Identity ADx DR model 5286, 5380, 5386 &5480 Verity ADx DR 5256, 5356 & 5456
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide and to four VA Medical Centers in IA and MO.
  • Product Description
    Pulse Generator
  • Manufacturer
    St Jude Medical

Manufacturer

St Jude Medical
  • Manufacturer Address
    St Jude Medical, 15900 Valley View Court, Sylmar CA 91342
  • Source
    USFDA