Medtronic, Inc. has recalled 77,510 Sphere-9 Catheters because they can interact with safety features in certain Biotronik heart devices (ICDs and CRT-Ds) during radiofrequency therapy. This interaction can cause a dangerous heart rhythm irregularity known as ventricular fibrillation (VF), which has been observed during therapy. Medtronic is advising medical facilities to use extreme caution when treating patients with these specific implanted heart devices and to have external defibrillators immediately available.
An interaction between the Sphere-9 catheter's current flow and the safety features of Biotronik implanted heart devices can trigger ventricular fibrillation (VF), a life-threatening heart rhythm where the heart cannot pump blood. Multiple observations of this interaction have already been reported.
Catheter used for treatment of atrial flutter. Affects patients with Biotronik ICD or CRT-D systems.
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Sources: FDA iRES · Raw API Response
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