Recall Z-0567-2013 ยท MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Medtronic Neuromodulation
Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba, Puerto Rico. Medtronic DBSTM Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Parkinson's Disease is indicated for adjunctive therapy in reducing som
| Date | Dec 19, 2012 (initiated Dec 3, 2012) |
| Status | Terminated |
| Reason | Medtronic has identified 140 Restore DBS Extension Kits (model numbers 7482, 37085, and 37086), which may contain a damaged winged connector boot. The connector boot may not have been molded properly and may be cracked. Approximately 14% of the 140 affected extension kits may contain a damaged radiopaque winged connector boot. |
| Root cause | Nonconforming Material/Component |
| Action | Medtronic beginning November 15, 2012 , initiated a retrieval of unused inventory in the field. In the US, three customers were identified. Medtronic field representatives visited these US accounts to facilitate product identification and removal. If product was removed a letter was provided to the facility describing the recall. The letter dated November 2012, "Medtronic Medical Device recall" was addressed to the Hospital. Beginning on December 3, 2012, Medtronic mailed healthcare professional letters to physician who have used the affected product. The Medtronic " Medical Device Recall |
| Quantity | 140 units |
| Distribution | Worldwide Distribution -- USA (nationwide) including the states of CT, MI, NH, NY, OH, PA and VT., and the countries of AUSTRALIA, JAPAN, BELGIUM, FRANCE, GERMANY, ITALY, NETHERLANDS, POLAND, SPAIN, SWITZERLAND, TURKEY and UNITED KINGDOM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.