Events

Recall of Device Recall Renamic and ICS 3000

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
    71658
  • Event Risk Class
    Class 2
  • Event Number
    Z-2376-2015
  • Event Initiated Date
    2015-06-30
  • Event Date Posted
    2015-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138606
  • 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
    Pacemaker/icd/crt non-implanted components - Product Code rce
  • Reason
    Ventricular packing: lv software programming versions for biotronik crt-p and crt-d devices are recalled because they are not approved for use in the us.
  • Action
    BIOTRONIK sent the Important Product Information letter and the Acknowledgement of Important Product Information Form, dated June 20, 2015, to affected physicians with the following recommendations: -Review programming settings for your patients with CRT-P or CRT-D devices. -If you have a patient with a device programmed to Ventricular pacing: LV, arrange to have the patients device reprogrammed to an appropriate approved mode (i.e. "Ventricular pacing: RV" or "Ventricular pacing: BiV"). -Physicians are requested to sign the Acknowledgement of Important Product Information Form and immediately fax to 800-913-6993 or email to UScompliance@biotronik.com. BIOTRONIK'S representative will update your programmer with approved 1502.U programmer software. Following this update, the Ventricular pacing: LV feature will no longer be available. However, a device previously programmed with "Ventricular pacing: LV will remain programmed in this mode unless and until the pacing mode setting is changed. If you have any questions concerning this Important Product Information, please contact the BIOTRONIK Technical Services Department: Telephone: 1-(800) 284-6689 (24-hour service)

Device

Device Recall Renamic and ICS 3000
  • Model / Serial
    Affected Product Part Numbers: 394229, 400335, 403222, 406797, 408849
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). || Allows physicians to program devices to pace exclusively in the left ventricle.
  • Manufacturer
    BIOTRONIK, Inc.

Manufacturer

BIOTRONIK, Inc.
  • Manufacturer Address
    BIOTRONIK, Inc., 6024 Jean Rd, Lake Oswego OR 97035-5571
  • Manufacturer Parent Company (2017)
    Micro Systems International Ag
  • 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