Events

Recall of Pulse Generators (aka pacemakers) || Models include: || Z-031-1 Meta DDR, Model 1256D || Z-032-1 Tempo VR, Model 1102 || Z-033-1 Tempo V, Model 1902 || Z-034-1 Tempo DR, Model 2101 || Z-035-1 Tempo D, Model 2902 || Z-036-1 Meta, Model 1256

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
    25102
  • Event Risk Class
    Class 2
  • Event Number
    Z-0341-03
  • Event Initiated Date
    2002-11-04
  • Event Date Posted
    2002-12-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25191
  • 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
    Potential loss of pacing function. expansion of recalls z-031-1 thru z-036-1.
  • Action
    Firm issued 'Dear Doctor' letters to following physicians which listed patient''s that the Doctor was responsible for. The letter informs of the situation regarding the potential loss of pacing function and recommends that the professional healthcare provider review and evaluate patients with the affected devices as soon as possible. Additional conditions to consider are specified for pacemaker dependent versus nondependent patients.

Device

Pulse Generators (aka pacemakers) || Models include: || Z-031-1 Meta DDR, Model 1256D || Z-032-1 ...
  • Model / Serial
    Serial numbers U6227335 to U6240907
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide and Australia, Austria, Belgium, Brazil, Canada, Cyprus, Czech Rep., France, Germany, Italy, Netherlands, Spain, Turkey, Venezuela.
  • Product Description
    Pulse Generators (aka pacemakers) || Models include: || Z-031-1 Meta DDR, Model 1256D || Z-032-1 Tempo VR, Model 1102 || Z-033-1 Tempo V, Model 1902 || Z-034-1 Tempo DR, Model 2101 || Z-035-1 Tempo D, Model 2902 || Z-036-1 Meta, Model 1256
  • Manufacturer
    St Jude Medical

Manufacturer

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