Events

Recall of Tachos

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

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
    28982
  • Event Risk Class
    Class 2
  • Event Number
    Z-0943-04
  • Event Initiated Date
    2004-04-29
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-04-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32912
  • 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 Cardioverter Defibrillator (Non-Crt) - Product Code LWS
  • Reason
    Potential for device to not deliver full amount of energy.
  • Action
    On 4/29/04 the firm issued 'Dear Doctor' letters to the physicians. The letter instructs the physician to schedule an immediate follow-up with all affected patients to determine if their devices are being impacted by the passivation buildup and to determine if device replacement is indicated.

Device

Tachos
  • Model / Serial
    Model Number 334 342 Serial numbers: 78050083 ¿ 78050088, 78050091 ¿ 78050095, 78050097, 78050098, 78050100, 78050103 ¿ 78050105, 78050107, 78050109, 78050110, 78050113, 78050117 ¿ 78050122, 78050124 ¿ 78050128, 78050133 ¿ 78050139, 78050142 ¿ 78050144, 78050162 ¿ 78050169
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Devices were distributed to physicians and medical centers throughout the U.S. The firm does not distribute internationally.
  • Product Description
    Tachos ATx
  • Manufacturer
    Biotronik Inc

Manufacturer

Biotronik Inc
  • Manufacturer Address
    Biotronik Inc, 6024 Jean Rd, Lake Oswego OR 97035-5308
  • Manufacturer comment
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    USFDA