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

Recall details

Manufacturer

Medtronic Neuromodulation

Distributor

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, Austria, Belarus, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, India, Iran, Iraq, Israel, Italy, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malta, Morocco, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, United Kingdom, Argentina, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Mexico, Panama, Peru, Puerto Rico, Uruguay, and Venezuela.

Lot

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, 0206917666, 0206917667, 0206917668, 0206917669, 0206917670, 0206917671, 0206920443, 0206920444, 0206920445, 0206920447, 0206920448, 0206920449, 0206920450, 0206920451, 0206920452, 0206920453, 0206920454, 0206920455, 0206920456, 0206920457, 0206920458, 0206920459, 0206920460, 0206920461, 0206920462, 0206920463, 0206920663, 0206920664, 0206920665, 0206920666, 0206920667, 0206920668, 0206920669, 0206920670, 0206920671, 0206920672, 0206920673, 0206924158, 0206924492, 0206924493, 0206924494, 0206924604, 0206924605, 0206924606, 0206924607, 0206924608, 0206924609, 0206924610, 0206924611, 0206924612, 0206924613, 0206924614, 0206924615, 0206924616, 0206924617, 0206924618, 0206924619, 0206925140, 0206925141, 0206925142, 0206925143, 0206925245, 0206925290, 0206925291, 0206925292, 0206926111, 0206926112, 0206926414, 0206929827, 0206929828, 0206929829, 0206929830, 0206929849, 0206930146, 0206930736, 0206930737, 0206930941, 0206930942, 0206930943, 0206931910, 0206931911, 0206931927, 0206931928, 0206933408, 0206934345, 0206934346, 0206934347, 0206937919, 0206937920, 0206942506, 0206946796, 0206946798, 0206949034, 0206949035, 0206950164, 0206955498, 0206955499, 0206956649, 0206956650, 0206957515, 0206957516, 0206957517, 0206957518, 0206957519, 0206957801, 0206957802, 0206957803, 0206957804, 0206957805, 0206957806, 0206957807, 0206959205, 0206959206, 0206959207, 0206959208, 0206959209, 0206959210, 0206959211, 0206959212, 0206959213, 0206959214, 0206959215, 0206959216, 0206959217, 0206959218, 0206959220, 0206959221, 0206959222, 0206959223, 0206959224, 0206959501, 0206959502, 0206959503, 0206959682, 0206959684, 0206959686, 0206959687, 0206960104, 0206960105, 0206960106, 0206960107, 0206960108, 0206960109, 0206960147, 0206960148, 0206960149, 0206960655, 0206960658, 0206960666, 0206960667, 0206960668, 0206960669, 0206960670, 0206960671, 0206960676, 0206960677, 0206960678, 0206960679, 0206960680, 0206960681, 0206960694, 0206960695, 0206960696, 0206969559, 0206969560, 0206969561, 0206969562, 0206969563, 0206969564, 0206969565, 0206969566, 0206969567, 0206969568, 0206969569, 0206969570, 0206969571, 0206969572, 0206969573, 0206969574, 0206969575, 0206969576, 0206969577, 0206969578, 0206969691, 0206969692, 0206970927, 0206973200, 0206973201, 0206973202, 0206973203, 0206973204, 0206973205, 0206973206, 0206973800, 0206973801, 0206978789, 0206980541, 0206980542, 0206980543, 0206980970, 0206980971, 0206981705, 0206981706, 0206981707, 0206981714, 0206981715, 0206981754, 0206981771, 0206981772, 0206984645, 0206984646, 0206984650, 0206984675, 0206991945, 0206991946, 0206991947, 0206991948, 0206991949, 0206991950, 0206991951, 0206991952, 0206991953, 0206991954, 0206991955, 0206991956, 0206991957, 0206991958, 0206991959, 0206991960, 0206991961, 0206991962, 0206991963, 0206991964, 0206991965, 0

Risk classification

Class II

Area (FDA)

device

Country

United States