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
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: jpuckeri@guidant.com
“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.”