CanadaThe Sphere-9™ Catheter (Model/catalogue AFR-00001; all lots) by Medtronic Inc. is affected. Forty-six incident reports (none from Canada) allege the Sphere-9 produces higher current flow to Biotronik ICDs and CRT‑Ds that can unfavorably modulate coupled currents (approx. 40 Hz) during RF ablation and may induce ventricular tachycardia or fibrillation. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Medtronic Inc., 710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432.
How to identify it
Affected products: Sphere-9™ Catheter; Lot or serial number: All lots.; Model or catalogue number: AFR-00001
The hazard
There have been forty-six (46) reported incident reports (none of which were from Canada) where patients with a Biotronik ICD experienced induced ventricular arrhythmia (VT and/or VF) following RF ablation of cardiac tissue using the Affera Sphere-9 catheter.
Sphere-9 presents a higher current flow to the ICD or CRT-D which interacts with a safety feature built into Biotronik ICDs and CRT-Ds. The higher currents of the Sphere-9 catheter during RF application proceed to an unfavorable modulation of the coupled currents (approx. 40Hz frequency) that may be conducted via the implanted leads, and result in possible VT or VF induction.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)