Safety Alert Or Field Safety Notices for INSIGNIA and NEXUS implantable pacemakers

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Guidant.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event Number
  • Date
  • Event Date Posted
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
  • Extra notes in the data
    Recall due to component failure.The information provided in this alert is an update to the information provided in MDA/2005/067 issued on 08 December 2005 which advised of two failure modes, which were described as: ‘First failure mode’ and ‘Second failure mode’.This Alert provides updated information concerning the second failure mode. There is no change to previous information provided about the first failure mode.Guidant has initiated a world-wide recall of certain INSIGNIA and NEXUS implantable pacemakers and has now identified why a subset of these devices exhibits no output conditions during verification testing prior to implant or during the implantation procedure (the second failure mode).Guidant has identified that these devices can malfunction if they incorporate a defective crystal timing component manufactured by one of two suppliers.Guidant has determined that a problem with the manufacturing process of this component can, in rare instances, result in a microscopic particle of quartz crystal entering the internal cavity of the crystal timing component. This particle can electrostatically attach to the inner surface of the crystal casing and subsequently detach through normal handling or during transit. The loose particle can then adhere to the crystal tuning mechanism causing crystal malfunction, and consequential malfunction of the master oscillator circuit that controls all pacemaker timing functions. Malfunction of the master oscillator will result in intermittent/permanent loss of pacing or telemetry.Although all models of INSIGNIA and NEXUS implantable pacemakers are affected, this recall is restricted to those devices that have been assembled using defective crystal timing components (see list of affected serial numbers distributed in the UK on our website).To date, Guidant has received 17 confirmed reports of device malfunction out of 257,000 devices distributed worldwide. These all occurred at pre-implant testing or during the implantation procedure.There have been no reports of device malfunction in the UK at pre-implant testing or during the implantation procedure. The number of potentially affected devices in the UK is approximately 8,000.Since all failures have occurred before or during the implantation procedure neither Guidant nor MHRA advise additional follow-up for successfully implanted devices at this time.Guidant also issued updated information related to this problem to UK clinicians on 16 December 2005 (see Appendix 1).MHRA will continue to monitor the situation and will consider issuing further advice.
  • Reason
    (guidant) component failure. (mda/2005/070).
  • Action
    Do not implant affected INSIGNIA or NEXUS implantable pacemakers Review stocks of INSIGNIA and NEXUS implantable pacemakers and identify those included in the recall. Immediately quarantine affected devices and return them to Guidant in accordance with their instructions. Report all instances of devices failure to MHRA and Guidant.


  • Model / Serial
  • Product Description
    Guidant INSIGNIA and NEXUS implantable pacemakers - specific serial numbers distributed in the UKDue to the number of products involved it is not possible to include the list of serial numbers on this page. A comprehensive list of serial numbers of affected devices distributed in the UK can be found in the following attachments:MDA/2005/070 - with model numbersList of serial numbers
  • Manufacturer


  • Manufacturer Address
    Enquiries to the manufacturer should be addressed to:Ms Jayne Puckeridge Regulatory Affairs Manager Guidant Limited Hampshire International Business Park Crockford Lane Chineham Basingstoke RG24 8WHTel: 01256 374 010Fax: 01256 374 014E-mail:
  • Manufacturer Parent Company (2017)
  • 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