Medtronic Sphere-9 Catheter — Class II medical device recall Z-1948-2026
Ongoing recall by Medtronic, Inc., reported 2026-05-06. Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter
| Recall number | Z-1948-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic, Inc., Mounds View, MN, United States |
| Recall initiated | 2026-03-11 |
| Classified | 2026-04-24 |
| Reported by FDA | 2026-05-06 |
| Quantity | 120,698 units |
| UPC / GTIN / UDI-DI | 00199150003709, 00199150003716, 00763000811341, 00763000871734, 00763000871741, 00763000911515, 00763000963675, 00763000973384, 00763000973391, 00763000973506, 00763000973513, 00763000993269 |
| Serial numbers | 0012573781, 0012576276, 0012578858, 0012583026, 0012583027, 0012590913, 0012590914, 0012594540, 0012594541, 0012609253, 0012609255, 0012609258, 0012614806, 0012614807, 0012614808, 0012619893, 0012619896, 0012619898, 0012619899, 0012623987, 0012623988, 0012623991, 0012631219, 0012631220, 0012631221 and 475 more |
| Model numbers | AFR-00001 |
Product
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Reason for recall
Ventricular fibrillation (VF) occurred 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1948-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.