# FDA recall Z-1948-2026

> **Medtronic, Inc.** · Class II · device recall initiated 2026-03-11.

## Product

Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.

## Reason for recall

ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observation is caused by an interaction between the Sphere-9 catheter current flow and a safety feature built into Biotronik ICDs and CRT Ds.  Medtronic recommends physicians use increased caution when using the Sphere-9 catheter for RF ablation therapy in patients implanted with a Biotronik ICD/CRT-D system, and to ensure external defibrillation systems are readily available.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-1948-2026
- **Recalling firm:** Medtronic, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-11
- **Report date:** 2026-05-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mounds View, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1948-2026

## Citation

> AI Analytics. FDA recall Z-1948-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1948-2026. Source: US FDA. Licensed CC0.

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