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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." }, { "resNumber": "Z-1098-2026", "productCode": "QAN", "status": "Open, Classified", "recallClass": "Class II", "initiated": "2025-12-04", "reason": "Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration." }, { "resNumber": "Z-0726-2026", "productCode": "LWS", "status": "Open, Classified", "recallClass": "Class II", "initiated": "2025-10-29", "reason": "There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur." }, { "resNumber": "Z-2168-2025", "productCode": "NVZ", "status": "Open, Classified", "recallClass": "Class II", "initiated": "2025-06-18", "reason": "In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery." }, { "resNumber": "Z-2169-2025", "productCode": "NVZ", "status": "Open, Classified", "recallClass": "Class II", "initiated": "2025-06-18", "reason": "In prior SmartSync application versions, the Abort button stopped the test that was selected. 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