Official recall record

Sphere-9™ Catheter

Health Canada · 2026-07-27 · CanadaType I

Issuing authority: Health Canada
Alert date: 2026-07-27
Country of alert: Canada
Alert level: Type I
Alert type: recall

What the authority reported

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

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — official record →
Record last checked against the registry on 2026-08-05.

More recalls: Health Canada · Canada · all filters

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.