Medtronic Neuromodulation Recall 89994
Description: Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
Medtronic Neuromodulation Recall 89994 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1129-2022 |
| Event ID | 89994 |
| Event Description | Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom. |
| Quantity | 1 unit |
| Recall Reason | The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system. |
| Device Classification | 20220601 |
| Device Code Info | Model: B35200; GTIN/UPN: 00763000420987; Serial number: NPI708734H; Expiration Date: 10/28/2022 |
| Center Classification Date | 20220524 |
| Recall Initiation Date | 20220330 |
| Recalling Firm | Medtronic Neuromodulation |
| Initial Notification | Letter |
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