Recall Z-3069-2017
Medtronic Neuromodulation · initiated March 17, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to multiple accessories used in DBS lead implant procedures. Among these accessories is the DBS lead holder, also referred to as the lead depth stop. The lead holder affixes to the DBS lead during the lead implant procedure, marking the distance to the lead tip and providing control of DBS lead depth during implant by interfacing with the stereotactic system
Codes / lots: Model 3387, Lot Serial #: 0206880294, 0206882647, 0206882779, 0206882780, 0206882781, 0206882782, 0206882783, 0206886184, 0206886323, 0206886328, 0206886330, 0206886331, 0206886332, 0206886333, 0206886603, 0206887813, 0206890443, 0206890444, 0206903488, 0206903489, 0206906792, 0206906793, 0206907159, 0206916391, 0206916392, 0206916393, 0206916394, 0206916395, 0206916396, 0206916397, 0206916398, 0206916399, 0206916797, 0206917120, 0206917121, 0206917122, 0206917123, 0206917124, 0206917125, 0206917126, 0206917127, 0206917128, 0206917129, 0206917130, 0206917131, 0206917132, 0206917302, 0206917303, 0206917304, 0206917306, 0206917307, 0206917308, 0206917310, 0206917312, 0206917560, 0206917561, 0206917563, 0206917564, 0206917565, 0206917566, 0206917568, 0206917569, 0206917570, 0206917572, 0206917573, 0206917574, 0206917575, 0206917576, 0206917577, 0206917578, 0206917579, 0206917620, 0206917621, 0206917622, 0206917623, 0206917624, 0206917625, 0206917626, 0206917627, 0206917628, 0206917629, 0206917630, 0206917631, 0206917632, 0206917633, 0206917634, 0206917635, 0206917636, 0206917637, 0206917638, 0206917639, 0206917660, 0206917661, 0206917662, 0206917663, 0206917664, 0206917665…
Reason for recall
Medtronic received reports that the DBS depth stop did not adequately secure to the lead, which can result in DBS lead placement beyond the intended target.
FDA-determined cause: Process control
Action taken
Medtronic sent an Urgent Medical Device Correction letter dated March 2017, to all affected consignees with important safety information on the use of the device. No product retrieval is involved at this time. The letter was addressed to Neurosurgeon. The letter described the product involved in the recall, provided information on the "Background", "Potential Risk to Patients", "Actions", & "Additional Information". For questions, contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7 am - pm CDT.
Details
- Recall number
- Z-3069-2017
- Initiated
- March 17, 2017
- Terminated
- April 22, 2021
- Product code
- MHY – Stimulator, Electrical, Implanted, For Parkinsonian Tremor
- Quantity
- 86,024
- Distribution
- Worldwide Distribution - US including AL, AR, AZ, CA,CO, CT, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,M MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. Foreign Distribution: India, ANZ, Taiwan, Hong Kong, Canada, China, Japan, Korea, Malaysia, Philippines, Singapore, Thailand, Indonesia, Vietnam, Albania, Algeria…
- Recalling firm
- Medtronic Neuromodulation, Minneapolis, MN