TELIGENTM implantable cardioverter defibrillators (ICD) and COGNISTM cardiac resynchronisation therapy devices (CRT-D) manufactured by Boston Scientific.The manufacturer has issued a Field Safety Notice (400Kb) (FSN) in relation to the second subset of affected devices. This notice has been distributed to clinics that have implanted these devices and conduct routine patient follow-up, and also to clinics equipped with compatible programmers.Device family
Affected model numbers
COGNIS CRT-D
N106/N107/N118/N119/P106/P107/P108
TELIGEN DR ICD
E110/F110/F111
TELIGEN VR ICD
E102/F102/F103You can check specific device–serial number combinations to find out if they are affected. This look-up tool differentiates newly identified devices from those already subject to the 2013 advisory notice.
“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.”