Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    GTIN 00643169890923: Serial/Lot Numbers: NPL0000474, NPL0000027, NPL0000072, NPL0000284, NPL0000561, NPL0003519, NPL0003792, NPL0000454, NPL0002036, NPL0004205, NPL0004222, NPL0003112, NPL0001300, NPL0003989, NPL0004099, NPL0004693, NPL0004711, NPL0004761, NPL0003189, NPL0001861, NPL0000740, NPL0001082, NPL0001698, NPL0001700, NPL0001703, NPL0003058, NPL0001697, NPL0003428, NPL0004076, NPL0001735, NPL0000971, NPL0002467, NPL0001025, NPL0000012, NPL0004605, NPL0002212, NPL0003070, NPL0000966, NPL0003890, NPL0001326, NPL0002948, NPL0000300, NPL0001081, NPL0003246, NPL0000325, NPL0000095, NPL0000756, NPL0002660, NPL0001100, NPL0002921, NPL0000548, NPL0000018, NPL0000170, NPL0003125, NPL0000495, NPL0003562, NPL0002336, NPL0002674, NPL0003293, NPL0003324, NPL0001498, NPL0004017, NPL0004018, NPL0000270, NPL0001652, NPL0001778, NPL0001937, NPL0001939, NPL0001940, NPL0001951, NPL0001990, NPL0002001, NPL0002380, NPL0002705, NPL0002913, NPL0003064, NPL0003516, NPL0003517, NPL0003530, NPL0003532, NPL0003599, NPL0003642, NPL0003643, NPL0004014, NPL0004890, NPL0004892, NPL0000470, NPL0003793, NPL0000391, NPL0000279, NPL0001050, NPL0000390, NPL0002715, NPL0001728, NPL0001730, NPL0003212, NPL0002174, NPL0004842, NPL0001060, NPL0000713, NPL0001079, NPL0000308, NPL0003196, NPL0003625, NPL0003197, NPL0004404, NPL0002896, NPL0003831, NPL0001059, NPL0003796, NPL0001042, NPL0002710, NPL0003235, NPL0004126, NPL0002552, NPL0000225, NPL0001400, NPL0003998, NPL0004153, NPL0002046, NPL0001084, NPL0001111, NPL0002053, NPL0002059, NPL0003820, NPL0004501, NPL0004502, NPL0004795, NPL0004799, NPL0004800, NPL0001708, NPL0003198, NPL0000466, NPL0002530, NPL0002544, NPL0000742, NPL0001651, NPL0004003, NPL0004698, NPL0002176, NPL0003478, NPL0001624, NPL0001879, NPL0004477, NPL0004482, NPL0001692, NPL0004910, NPL0004363, NPL0003474, NPL0001064, NPL0001090, NPL0001603, NPL0001619, NPL0001667, NPL0001713, NPL0004364, NPL0004606, NPL0004701, NPL0002627, NPL0000043, NPL0002607, NPL0002626, NPL0004160, NPL0002554, NPL0002555, NPL0000980, NPL0001216, NPL0000221, NPL0003959, NPL0001707, NPL0004846, NPL0004058, NPL0003749, NPL0003210, NPL0001241, NPL0001246, NPL0001288, NPL0002648, NPL0003234, NPL0003241, NPL0002556, NPL0003222, NPL0001238, NPL0001258, NPL0002480, NPL0003292, NPL0001661, NPL0001662, NPL0001789, NPL0003283, NPL0003815, NPL0003947, NPL0001321, NPL0002565, NPL0004621, NPL0004652, NPL0001240, NPL0002657, NPL0002658, NPL0001271, NPL0003071, NPL0001718, NPL0002711, NPL0002712, NPL0001274, NPL0002610, NPL0004906, NPL0001017, NPL0003997, NPL0004023, NPL0003462, NPL0002401, NPL0002403, NPL0001716, NPL0001717, NPL0004904, NPL0002462, NPL0004893, NPL0004894, NPL0004896, NPL0002846, NPL0002848, NPL0001591, NPL0003490, NPL0001270, NPL0001028, NPL0002696, NPL0002773, NPL0001768, NPL0001466, NPL0001289, NPL0001791, NPL0004662, NPL0001245, NPL0003986, NPL0001208, NPL0001209, NPL0001272, NPL0001239, NPL0001053, NPL0001055, NPL0002891, NPL0001333, NPL0001345, NPL0002659, NPL0002725, NPL0003975, NPL0003329, NPL0002304, NPL0001828, NPL0001829, NPL0001275, NPL0002477, NPL0004801, NPL0002196, NPL0004149, NPL0004783, NPL0004784, NPL0002536, NPL0001242, NPL0001276, NPL0002944, NPL0002946, NPL0002947, NPL0002985, NPL0003459, NPL0002413, NPL0003737, NPL0004162, NPL0003200, NPL0002019, NPL0001231, NPL0004016, NPL0004577, NPL0002326, NPL0004494, NPL0004520, NPL0001612, NPL0003601, NPL0003602, NPL0004521, NPL0004674, NPL0002016, NPL0002133, NPL0003372, NPL0004274, NPL0003063, NPL0003228, NPL0003240, NPL0003208, NPL0001252, NPL0001478, NPL0002039, NPL0003784, NPL0003800, NPL0001296, NPL0001312, NPL0001314, NPL0001317, NPL0001318, NPL0001319, NPL0002428, NPL0003059, NPL0003463, NPL0003464, NPL0003466, NPL0004202, NPL0001373, NPL0001383, NPL0001384, NPL0001394, NPL0001396, NPL0001501, NPL0003838, NPL0002895, NPL0002969, NPL0003122, NPL0003458, NPL0004050, NPL0001441, NPL0001445, NPL0001051, NPL0001315, NPL0001316, NPL0001674, NPL0001819, NPL0004221, NPL0004601, NPL0001393, NPL0001083, NPL0003094, NPL0003095, NPL0003096, NPL0003341, NPL0003460, NPL0003992, NPL0004060, NPL0003188, NPL0001540, NPL0002008, NPL0002540, NPL0002541, NPL0002640, NPL0002706, NPL0001105, NPL0002548, NPL0002561, NPL0002667, NPL0002668, NPL0003715, NPL0003716, NPL0003763, NPL0004377, NPL0001070, NPL0001099, NPL0001571, NPL0001926, NPL0003179, NPL0003190, NPL0003973, NPL0003974, NPL0004052, NPL0004532, NPL0004533, NPL0001259, NPL0003269, NPL0001061, NPL0001106, NPL0001378, NPL0001403, NPL0001414, NPL0004011, NPL0004609, NPL0004668, NPL0004680, NPL0001171, NPL0001821, NPL0001822, NPL0001823, NPL0001812, NPL0003172, NPL0003174, NPL0003175, NPL0003272, NPL0003720, NPL0003205, NPL0003217, NPL0001291, NPL0003777, NPL0001817, NPL0002823, NPL0003346, NPL0003983, NPL0004107, NPL0004118, NPL0004370, NPL0001530, NPL0002577, NPL0002824, NPL0004105, NPL0001759, NPL0001813, NPL0001814, NPL0001815, NPL0001818, NPL0001854, NPL0003369, NPL0004037, NPL0001301, NPL0001302, NPL0001307, NPL0001308, NPL0001310, NPL0001311, NPL0001328, NPL0001329, NPL0001355, NPL0001938, NPL0001253, NPL0002436, NPL0002437, NPL0003252, NPL0002522, NPL0002738, NPL0004312, NPL0004314, NPL0004316, NPL0001950, NPL0001976, NPL0002000, NPL0002003, NPL0001137, NPL0001013, NPL0001074, NPL0001075, NPL0001009, NPL0000743, NPL0000746, NPL0000554, NPL0000051
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Medtronic Neuromodulation
Reason for Recall:
Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A

Product Codes/Lot Numbers:

GTIN 00643169890923: Serial/Lot Numbers: NPL0000474, NPL0000027, NPL0000072, NPL0000284, NPL0000561, NPL0003519, NPL0003792, NPL0000454, NPL0002036, NPL0004205, NPL0004222, NPL0003112, NPL0001300, NPL0003989, NPL0004099, NPL0004693, NPL0004711, NPL0004761, NPL0003189, NPL0001861, NPL0000740, NPL0001082, NPL0001698, NPL0001700, NPL0001703, NPL0003058, NPL0001697, NPL0003428, NPL0004076, NPL0001735, NPL0000971, NPL0002467, NPL0001025, NPL0000012, NPL0004605, NPL0002212, NPL0003070, NPL0000966, NPL0003890, NPL0001326, NPL0002948, NPL0000300, NPL0001081, NPL0003246, NPL0000325, NPL0000095, NPL0000756, NPL0002660, NPL0001100, NPL0002921, NPL0000548, NPL0000018, NPL0000170, NPL0003125, NPL0000495, NPL0003562, NPL0002336, NPL0002674, NPL0003293, NPL0003324, NPL0001498, NPL0004017, NPL0004018, NPL0000270, NPL0001652, NPL0001778, NPL0001937, NPL0001939, NPL0001940, NPL0001951, NPL0001990, NPL0002001, NPL0002380, NPL0002705, NPL0002913, NPL0003064, NPL0003516, NPL0003517, NPL0003530, NPL0003532, NPL0003599, NPL0003642, NPL0003643, NPL0004014, NPL0004890, NPL0004892, NPL0000470, NPL0003793, NPL0000391, NPL0000279, NPL0001050, NPL0000390, NPL0002715, NPL0001728, NPL0001730, NPL0003212, NPL0002174, NPL0004842, NPL0001060, NPL0000713, NPL0001079, NPL0000308, NPL0003196, NPL0003625, NPL0003197, NPL0004404, NPL0002896, NPL0003831, NPL0001059, NPL0003796, NPL0001042, NPL0002710, NPL0003235, NPL0004126, NPL0002552, NPL0000225, NPL0001400, NPL0003998, NPL0004153, NPL0002046, NPL0001084, NPL0001111, NPL0002053, NPL0002059, NPL0003820, NPL0004501, NPL0004502, NPL0004795, NPL0004799, NPL0004800, NPL0001708, NPL0003198, NPL0000466, NPL0002530, NPL0002544, NPL0000742, NPL0001651, NPL0004003, NPL0004698, NPL0002176, NPL0003478, NPL0001624, NPL0001879, NPL0004477, NPL0004482, NPL0001692, NPL0004910, NPL0004363, NPL0003474, NPL0001064, NPL0001090, NPL0001603, NPL0001619, NPL0001667, NPL0001713, NPL0004364, NPL0004606, NPL0004701, NPL0002627, NPL0000043, NPL0002607, NPL0002626, NPL0004160, NPL0002554, NPL0002555, NPL0000980, NPL0001216, NPL0000221, NPL0003959, NPL0001707, NPL0004846, NPL0004058, NPL0003749, NPL0003210, NPL0001241, NPL0001246, NPL0001288, NPL0002648, NPL0003234, NPL0003241, NPL0002556, NPL0003222, NPL0001238, NPL0001258, NPL0002480, NPL0003292, NPL0001661, NPL0001662, NPL0001789, NPL0003283, NPL0003815, NPL0003947, NPL0001321, NPL0002565, NPL0004621, NPL0004652, NPL0001240, NPL0002657, NPL0002658, NPL0001271, NPL0003071, NPL0001718, NPL0002711, NPL0002712, NPL0001274, NPL0002610, NPL0004906, NPL0001017, NPL0003997, NPL0004023, NPL0003462, NPL0002401, NPL0002403, NPL0001716, NPL0001717, NPL0004904, NPL0002462, NPL0004893, NPL0004894, NPL0004896, NPL0002846, NPL0002848, NPL0001591, NPL0003490, NPL0001270, NPL0001028, NPL0002696, NPL0002773, NPL0001768, NPL0001466, NPL0001289, NPL0001791, NPL0004662, NPL0001245, NPL0003986, NPL0001208, NPL0001209, NPL0001272, NPL0001239, NPL0001053, NPL0001055, NPL0002891, NPL0001333, NPL0001345, NPL0002659, NPL0002725, NPL0003975, NPL0003329, NPL0002304, NPL0001828, NPL0001829, NPL0001275, NPL0002477, NPL0004801, NPL0002196, NPL0004149, NPL0004783, NPL0004784, NPL0002536, NPL0001242, NPL0001276, NPL0002944, NPL0002946, NPL0002947, NPL0002985, NPL0003459, NPL0002413, NPL0003737, NPL0004162, NPL0003200, NPL0002019, NPL0001231, NPL0004016, NPL0004577, NPL0002326, NPL0004494, NPL0004520, NPL0001612, NPL0003601, NPL0003602, NPL0004521, NPL0004674, NPL0002016, NPL0002133, NPL0003372, NPL0004274, NPL0003063, NPL0003228, NPL0003240, NPL0003208, NPL0001252, NPL0001478, NPL0002039, NPL0003784, NPL0003800, NPL0001296, NPL0001312, NPL0001314, NPL0001317, NPL0001318, NPL0001319, NPL0002428, NPL0003059, NPL0003463, NPL0003464, NPL0003466, NPL0004202, NPL0001373, NPL0001383, NPL0001384, NPL0001394, NPL0001396, NPL0001501, NPL0003838, NPL0002895, NPL0002969, NPL0003122, NPL0003458, NPL0004050, NPL0001441, NPL0001445, NPL0001051, NPL0001315, NPL0001316, NPL0001674, NPL0001819, NPL0004221, NPL0004601, NPL0001393, NPL0001083, NPL0003094, NPL0003095, NPL0003096, NPL0003341, NPL0003460, NPL0003992, NPL0004060, NPL0003188, NPL0001540, NPL0002008, NPL0002540, NPL0002541, NPL0002640, NPL0002706, NPL0001105, NPL0002548, NPL0002561, NPL0002667, NPL0002668, NPL0003715, NPL0003716, NPL0003763, NPL0004377, NPL0001070, NPL0001099, NPL0001571, NPL0001926, NPL0003179, NPL0003190, NPL0003973, NPL0003974, NPL0004052, NPL0004532, NPL0004533, NPL0001259, NPL0003269, NPL0001061, NPL0001106, NPL0001378, NPL0001403, NPL0001414, NPL0004011, NPL0004609, NPL0004668, NPL0004680, NPL0001171, NPL0001821, NPL0001822, NPL0001823, NPL0001812, NPL0003172, NPL0003174, NPL0003175, NPL0003272, NPL0003720, NPL0003205, NPL0003217, NPL0001291, NPL0003777, NPL0001817, NPL0002823, NPL0003346, NPL0003983, NPL0004107, NPL0004118, NPL0004370, NPL0001530, NPL0002577, NPL0002824, NPL0004105, NPL0001759, NPL0001813, NPL0001814, NPL0001815, NPL0001818, NPL0001854, NPL0003369, NPL0004037, NPL0001301, NPL0001302, NPL0001307, NPL0001308, NPL0001310, NPL0001311, NPL0001328, NPL0001329, NPL0001355, NPL0001938, NPL0001253, NPL0002436, NPL0002437, NPL0003252, NPL0002522, NPL0002738, NPL0004312, NPL0004314, NPL0004316, NPL0001950, NPL0001976, NPL0002000, NPL0002003, NPL0001137, NPL0001013, NPL0001074, NPL0001075, NPL0001009, NPL0000743, NPL0000746, NPL0000554, NPL0000051

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0911-2023

Related Recalls

Class I - Dangerous

Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.

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