Product Wiki · Recalls · Health Canada — Medical Devices

Sphere-9™ Catheter — recall 82409

Health Canada — Medical Devices · Canada · 2026-07-27 · Type I

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
82409
Date of alert
2026-07-27
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Cardiovascular
Product type
Medical devices
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/sphere-9tm-catheter

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.