Medical Device Recalls

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New Search Back to Search Results   Class 2 Recall Interstim for Urinary Control Date Posted October 11, 2007 Recall Number Z-0037-2008 Product Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N'Vision with a Clinic an Programmer Model 8840. Implantable Neurostimulator for Urinary Control. Code Information All serial numbers within these catalog/model numbers are affected: Model 3058, Catalog # 8870MM01 & 8870NNB01 Recalling Firm/ Manufacturer Medtronic Neuromodulation 800 53rd Ave NE PO Box 1250 Minneapolis, Minnesota 55440-1250 Reason for Recall A software issue may cause a lower than expected battery capacity estimate when evaluating an InterStim II Implantable Neurostimulator (model 3058) with an N'Vision Clinician Programmer(Model 8840) before implant . Action Begining on July 11, 2007 a letter to the physicians was sent informing them of the issue and patient mangement of the two issues. The letter includes a Cover Letter, A Reply Form, and two Recall letters explaining the issue in detail. Quantity in Commerce 1885 Distribution Nationwide and the Netherlands.