Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01510-1
Product Name/Description Valitude CRT-P, Resonate, Momentum & Autogen CRT-Ds, Visionist CRT-P & Dynagen CRT-D

Model U128
ARTG 279333

Model G447
ARTG 296562

Models G124, G125, G126, G128
ARTG 296563, 296564, 296565, 296566

Models G172, G173, G175, G177, G179
ARTG 221615, 221616, 221617, 221618, 221633

Models U225, U226, U228
ARTG 279330, 279331, 279332

Models G151, G156, G158
ARTG 221620, 221621, 221622
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 20/12/2017
Responsible Entity Boston Scientific Pty Ltd
Reason/Issue Boston Scientific has been made aware of unintended asynchronous biventricular (BiV) pacing behaviour when tracking elevated atrial intrinsic rhythms in certain Boston Scientific Cardiac Resynchronisation Therapy (CRT) pacemakers (CRT-Ps) and defibrillators (CRT-Ds). Repeated detection of this unintended asynchronous BiV pacing behaviour may result in the implanted device reverting to a permanent Safety Mode (Safety Core) status thus requiring early replacement.
Recall Action Recall for Product Correction
Recall Action Instructions Doctors should review programming records of patients implanted with the CRT devices described in Appendix B of the letter. If the LV Offset parameter is programmed to a Positive value, follow the supplied instructions to determine the need for changing the pacemaker settings.
Boston encourages doctors to provide the patient letter to all patients who are implanted with an affected device, and to patients who consent to having the device implanted before the software fix is available.
Maintain awareness of this issue until the software fix becomes available, and display this letter in a prominent place.
If a positive LV Offset is desired for a newly implanted Boston Scientific CRT device, consider the patient’s individual medical needs and either program the A-Blank after V-Pace value greater than the positive LV Offset value, or disable Tracking Preference by programming it to a value of “OFF”.

This action has been closed out on 14/04/2020
Contact Information 02 8063 8299 - Boston Scientific Technical Services