Recall archive / FDA device enforcement
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following dev... — FDA record Z-2201-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 8, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B; 3. PROG CT900C CLINICIAN TABLET UK, Model Number CT900C; 4. PROG CT900D CLINICIAN TABLET GLOBAL, Model Number CT900D; 5. PROG CT900E CLINICIAN TABLET GLBL SMSNG, Model Number CT900E; 6. PROG CT900F CLINICIAN TABLET GLBL SMSNG, Model Number CT900F; implanted programmable infusion pump
- Reason
- Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.
- Classification
- Class II
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 10165 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2201-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Software application (app) version 1.x and 2.x, loaded on the following units: 1. Model Number CT900A, GTIN 00643169890923, Serial Numbers: NPL0004445; 2. Model Number CT900B, GTIN 00643169890947, Serial Numbers: NPL1000042, NPL1000045, NPL1000046, NPL1000048, NPL1000050, NPL1000051, NPL1000053, NPL1000054, NPL1000059, NPL1000060, NPL1000062, NPL1000065, NPL1000069, NPL1000070, NPL1000071, NPL1000072, NPL1000073, NPL1000074, NPL1000075, NPL1000077, NPL1000081, NPL1000082, NPL1000083, NPL1000085, NPL1000086, NPL1000087, NPL1000090, NPL1000091, NPL1000093, NPL1000094, NPL1000098, NPL1000117, NPL1000133, NPL1000135, NPL1000137, NPL1000138, NPL1000151, NPL1000159, NPL1000160, NPL1000164, NPL1000166, NPL1000167, NPL1000169, NPL1000173, NPL1000174, NPL1000179, NPL1000180, NPL1000183, NPL1000185, NPL1000186, NPL1000187, NPL1000188, NPL1000191, NPL1000192, NPL1000193, NPL1000194, NPL1000195, NPL1000196, NPL1000230, NPL1000235, NPL1000237, NPL1000242, NPL1000244, NPL1000245, NPL1000246, NPL1000248, NPL1000249, NPL1000252, NPL1000254, NPL1000257, NPL1000258, NPL1000281, NPL1000292, NPL1000297, NPL1000301, NPL1000303, NPL1000307, NPL1000321, NPL1000322, NPL1000323, NPL1000325, NPL1000326, NPL1000332, NPL1000334, NPL1000343, NPL1000361, NPL1000362, NPL1000363, NPL1000364, NPL1000365, NPL1000366, NPL1000367, NPL1000369, NPL1000370, NPL1000381, NPL1000483, NPL1000486, NPL1000487, NPL1000501, NPL1000502, NPL1000505, NPL1000506, NPL1000507, NPL1000509, NPL1000510, NPL1000512, NPL1000515, NPL1000516, NPL1000518, NPL1000519, NPL1000528, NPL1000529, NPL1000539, NPL1000540, NPL1000555, NPL1000556, NPL1000558, NPL1000560, NPL1000561, NPL1000562, NPL1000563, NPL1000564, NPL1000571, NPL1000573, NPL1000574, NPL1000575, NPL1000576, NPL1000577, NPL1000578, NPL1000580, NPL1000585, NPL1000592, NPL1000603, NPL1000606, NPL1000612, NPL1000627, NPL1000630, NPL1000631, NPL1000632, NPL1000634, NPL1000637, NPL1000641, NPL1000652, NPL1000653, NPL1001194, NPL1001195, NPL1001201, NPL1001204, NPL1001205, NPL1001206, NPL1001207, NPL1001208, NPL1001210, NPL1001211, NPL1001212, NPL1001216, NPL1001223, NPL1001224, NPL1001225, NPL1001226, NPL1001228, NPL1001229, NPL1001230, NPL1001231, NPL1001235, NPL1001236, NPL1001237, NPL1001238, NPL1001240, NPL1001241, NPL1001243, NPL1001244, NPL1001250, NPL1001251, NPL1001254, NPL1001259, NPL1001264, NPL1001265, NPL1001272, NPL1001273, NPL1001274, NPL1001277, NPL1001282, NPL1001283, NPL1001290, NPL1001291, NPL1001306, NPL1001307, NPL1001313, NPL1001314, NPL1001328, NPL1001330, NPL1001332, NPL1001333, NPL1001334, NPL1001336, NPL1001337, NPL1001339, NPL1001341, NPL1001345, NPL1001349, NPL1001350, NPL1001351, NPL1001353, NPL1001354, NPL1001360, NPL1001361, NPL1001362, NPL1001366, NPL1001367, NPL1001369, NPL1001372, NPL1001375, NPL1001380, NPL1001381, NPL1001385, NPL1001386, NPL1001389, NPL1001398, NPL1001407, NPL1001408, NPL1001410, NPL1001412, NPL1001419, NPL1001421, NPL1001423, NPL1001430, NPL1001431, NPL1001434, NPL1001435, NPL1001436, NPL1001439, NPL1001445, NPL1001449, NPL1001458, NPL1001461, NPL1001464, NPL1001465, NPL1001468, NPL1001482, NPL1001483, NPL1001486, NPL1001499, NPL1001500, NPL1001505, NPL1001507, NPL1001510, NPL1001512, NPL1001513, NPL1001514, NPL1001518, NPL1001520, NPL1001524, NPL1001526, NPL1001531, NPL1001532, NPL1001537, NPL1001539, NPL1001540, NPL1001541, NPL1001542, NPL1001544, NPL1001545, NPL1001546, NPL1001547, NPL1001549, NPL1001550, NPL1001678, NPL1001689, NPL1001694, NPL1001695, NPL1001697, NPL1001699, NPL1001700, NPL1001701, NPL1001702, NPL1001705, NPL1001707, NPL1001708, NPL1001709, NPL1001710, NPL1001711, NPL1001716, NPL1001717, NPL1001723, NPL1001724, NPL1001727, NPL1001728, NPL1001739, NPL1001740, NPL1001741, NPL1001742, NPL1001743, NPL1001744, NPL1001745, NPL1001748, NPL1001749, NPL1001750, NPL1001754, NPL1001755, NPL1001756, NPL1001757, NPL1001759, NPL1001760, NPL1001761, NPL1001763, NPL1001764, NPL1001765, NPL1001766, NPL1001767, NPL1001769, NPL1001770, NPL1001773, NPL1001777, NPL1001784, NPL1001787, NPL1001789, NPL1001792, NPL1001794, NPL1001795, NPL1001797, NPL1001798, NPL1001799, NPL1001800, NPL1001801, NPL1001803, NPL1001804, NPL1001805, NPL1001806, NPL1001811, NPL1001812, NPL1001815, NPL1001816, NPL1001817, NPL1001820, NPL1001823, NPL1001824, NPL1001825, NPL1001829, NPL1001830, NPL1001833, NPL1001841, NPL1001842, NPL1001843, NPL1001844, NPL1001847, NPL1001875, NPL1001876, NPL1001877, NPL1001879, NPL1001880, NPL1001881, NPL1001882, NPL1001884, NPL1001885, NPL1001886, NPL1001887, NPL1001888, NPL1001889, NPL1001891, NPL1001897, NPL1001899, NPL1001900, NPL1001901, NPL1001903, NPL1001904, NPL1001905, NPL1001937, NPL1001940, NPL1001946, NPL1001947, NPL1001948, NPL1001950, NPL1001955, NPL1001957, NPL1001959, NPL1001963, NPL1001966, NPL1001968, NPL1001969, NPL1001970, NPL1001971, NPL1001972, NPL1001973, NPL1001974, NPL1001975, NPL1001976, NPL1001977, NPL1001995, NPL1001996, NPL1002004, NPL1002007, NPL1002010, NPL1002016, NPL1002020, NPL1002021, NPL1002025, NPL1002034, NPL1002035, NPL1002038, NPL1002048, NPL1002049, NPL1002050, NPL1002051, NPL1002053, NPL1002054, NPL1002064, NPL1002065, NPL1002066, NPL1002067, NPL1002068, NPL1002088, NPL1002089, NPL1002090, NPL1002091, NPL1002092, NPL1002093, NPL1002094, NPL1002095, NPL1002124, NPL1002126, NPL1002132, NPL1002137, NPL1002146, NPL1002152, NPL1002190, NPL1002191, NPL1002192, NPL1002194, NPL1002200, NPL1002203, NPL1002211, NPL1002214, NPL1002219, NPL1002221, NPL1002222, NPL1002223, NPL1002224, NPL1002225, NPL1002226, NPL1002227, NPL1002228, NPL1002229, NPL1002230, NPL1002231, NPL1002232, NPL1002233, NPL1002234, NPL1002236, NPL1002238, NPL1002239, NPL1002240, NPL1002243, NPL1002244, NPL1002245, NPL1002246, NPL1002247, NPL1002254, NPL1002255, NPL1002256, NPL1002311, NPL1002312, NPL1002313, NPL1002316, NPL1002324, NPL1002329, NPL1002330, NPL1002334, NPL1002335, NPL1002337, NPL1002338, NPL1002339, NPL1002340, NPL1002341, NPL1002342, NPL1002343, NPL1002344, NPL1002347, NPL1002349, NPL1002355, NPL1002356, NPL1002357, NPL1002358, NPL1002359, NPL1002360, NPL1002361, NPL1002362, NPL1002363, NPL1002364, NPL1002367, NPL1002368, NPL1002369, NPL1002370, NPL1002371, NPL1002373, NPL1002375, NPL1002380, NPL1002381, NPL1002382, NPL1002383, NPL1002386, NPL1002392, NPL1002396, NPL1002399, NPL1002401, NPL1002405, NPL1002408, NPL1002409, NPL1002410, NPL1002411, NPL1002412, NPL1002413, NPL1002414, NPL1002415, NPL1002416, NPL1002417, NPL1002418, NPL1002421, NPL1002427, NPL1002428, NPL1002431, NPL1002436, NPL1002438, NPL1002443, NPL1002445, NPL1002460, NPL1002461, NPL1002462, NPL1002464, NPL1002465, NPL1002466, NPL1002467, NPL1002470, NPL1002471, NPL1002474, NPL1002482, NPL1002484, NPL1002490, NPL1002491, NPL1002495, NPL1002496, NPL1002499, NPL1002500, NPL1002501, NPL1002502, NPL1002503, NPL1002505, NPL1002508, NPL1002521, NPL1002530, NPL1002537, NPL1002540, NPL1002544, NPL1002545, NPL1002548, NPL1002549, NPL1002555, NPL1002556, NPL1002557, NPL1002564, NPL1002567, NPL1002568, NPL1002572, NPL1002592, NPL1002593, NPL1002594, NPL1002595, NPL1002596, NPL1002613, NPL1002616, NPL1002617, NPL1002618, NPL1002620, NPL1002626, NPL1002628, NPL1002630, NPL1002631, NPL1002632, NPL1002636, NPL1002637, NPL1002638, NPL1002639, NPL1002640, NPL1002642, NPL1002646, NPL1002648, NPL1002650, NPL1002651, NPL1002652, NPL1002653, NPL1002654, NPL1002656, NPL1002659, NPL1002661, NPL1002666, NPL1002668, NPL1002669, NPL1002671, NPL1002673, NPL1002677, NPL1002679, NPL1002684, NPL1002685, NPL1002686, NPL1002687, NPL1002689, NPL1002690, NPL1002693, NPL1002695, NPL1002696, NPL1002698, NPL1002706, NPL1002709, NPL1002710, NPL1002711, NPL1002712, NPL1002714, NPL1002718, NPL1002719, NPL1002720, NPL1002721, NPL1002728, NPL1002729, NPL1002730, NPL1002731, NPL1002732, NPL1002733, NPL1002735, NPL1002736, NPL1002737, NPL1002739, NPL1002740, NPL1002741, NPL1002743, NPL1002753, NPL1002756, NPL1002757, NPL1002760, NPL1002761, NPL1002778, NPL1002779, NPL1002780, NPL1002781, NPL1002784, NPL1002786, NPL1002787, NPL1002789, NPL1002791, NPL1002792, NPL1002794, NPL1002796, NPL1002800; 3. Model Number CT900C, GTIN 00643169890961, Serial Numbers: NPL1000429, NPL1000430, NPL1000442, NPL1000443, NPL1000444, NPL1000445, NPL1000446, NPL1000447, NPL1000448, NPL1000451, NPL1000453, NPL1000771, NPL1000774, NPL1000776, NPL1000777, NPL1000780, NPL1000781, NPL1000794, NPL1000795, NPL1000797, NPL1000798, NPL1000799, NPL1000802, NPL1000804, NPL1000805, NPL1000806, NPL1000808, NPL1000809, NPL1000810, NPL1000811, NPL1000813, NPL1000814, NPL1000815, NPL1000817, NPL1000818, NPL1000819, NPL1000827, NPL1000830, NPL1000832, NPL1000833, NPL1000834, NPL1000835, NPL1000838, NPL1000845, NPL1000847, NPL1000854, NPL1000855, NPL1000858, NPL1001552, NPL1001562, NPL1001564, NPL1001565, NPL1001566, NPL1001570, NPL1001571, NPL1001574, NPL1001582, NPL1001583, NPL1001588, NPL1001590, NPL1001591, NPL1001592, NPL1001594, NPL1001595, NPL1001596, NPL1001601, NPL1001602, NPL1001605, NPL1001606, NPL1001607, NPL1001608, NPL1001609, NPL1001610, NPL1001611, NPL1001615, NPL1001617, NPL1001618, NPL1001620, NPL1001621, NPL1001627, NPL1001629, NPL1001630, NPL1001631, NPL1001632, NPL1001637, NPL1001638, NPL1001644, NPL1001645, NPL1001647, NPL1001649, NPL1001650, NPL1001651, NPL1001652, NPL1001656, NPL1001657, NPL1001670, NPL1001673, NPL1001675, NPL1002257, NPL1002259, NPL1002260, NPL1002262, NPL1002264, NPL1002265, NPL1002266, NPL1002267, NPL1002268, NPL1002275, NPL1002279, NPL1002280, NPL1002281, NPL1002282, NPL1002284, NPL1002285, NPL1002286, NPL1002288, NPL1002294, NPL1002295, NPL1002297, NPL1002298, NPL1002306, NPL1002307, NPL1002308, NPL1002309, NPL1002310; 4. Model Number CT900D, (1) GTIN 00763000077730, Serial Numbers: NPL3000277, NPL3000278, NPL3000279, NPL3000280, NPL3000281, NPL3000282, NPL3000283, NPL3000285, NPL3000290, NPL3000292, NPL3000293, NPL3000298, NPL3000299, NPL3000300, NPL3000301, NPL3000304, NPL3000305, NPL3000309, NPL3000310, NPL3000312, NPL3000460, NPL3000555, NPL3000563, NPL3000582, NPL3000590, NPL3000591, NPL3002090, NPL3002102, NPL3002311, NPL3002312, NPL3002313, NPL3002314, NPL3002315, NPL3002316, NPL3002318, NPL3002760, NPL3002761, NPL3002762, NPL3002763, NPL3002816, NPL3002995, NPL3002997, NPL3002998, NPL3002999, NPL3003000, NPL3003001, NPL3003002, NPL3003003, NPL3003004, NPL3003005, NPL3003009, NPL3003010, NPL3003011, NPL3003012, NPL3003013, NPL3003014, NPL3003015, NPL3003016, NPL3003018, NPL3003021, NPL3003022, NPL3003023, NPL3003024, NPL3003026, NPL3003028, NPL3003029, NPL3003030, NPL3003031, NPL3003032, NPL3003036, NPL3003037, NPL3003038, NPL3003042, NPL3003046, NPL3003048, NPL3003050, NPL3003051, NPL3003054, NPL3003059, NPL3003060, NPL3003062, NPL3003065, NPL3003067, NPL3003068, NPL3003070, NPL3003072, NPL3003073, NPL3003074, NPL3003076, NPL3003077, NPL3003078, NPL3003086, NPL3003260, NPL3003267, NPL3003268, NPL3003271, NPL3003275, NPL3003277, NPL3003280, NPL3003282, NPL3003283, NPL3003284, NPL3003402, NPL3003409, NPL3003412, NPL3003413, NPL3003415, NPL3003416, NPL3003417, NPL3003418, NPL3003419, NPL3003420, NPL3003422, NPL3003423, NPL3003425, NPL3003427, NPL3003513, NPL3003517, NPL3003518, NPL3003521, NPL3003524, NPL3003528, NPL3003529, NPL3003530, NPL3003532, NPL3003533, NPL3003534, NPL3003535, NPL3003536, NPL3003537, NPL3003538, NPL3003539, NPL3003540, NPL3003542, NPL3003543, NPL3003544, NPL3003545, NPL3003546, NPL3003547, NPL3003548, NPL3003549, NPL3003551, NPL3003552, NPL3003558, NPL3003560, NPL3003566, NPL3003567, NPL3003569, NPL3003570, NPL3003576, NPL3003577, NPL3003578, NPL3003579, NPL3003580, NPL3003581, NPL3003598, NPL3003599, NPL3003601, NPL3003745, NPL3003756, NPL3003766, NPL3003817, NPL3003821, NPL3003823, NPL3003824, NPL3003850, NPL3003885, NPL3003886, NPL3003887, NPL3003890, NPL3003891, NPL3003892, NPL3003893, NPL3003894, NPL3003895, NPL3003896, NPL3003897, NPL3003899, NPL3003900, NPL3003901, NPL3003904, NPL3003905, NPL3003906, NPL3003907, NPL3003921, NPL3003923, NPL3003924, NPL3003929, NPL3003943, NPL3003944, NPL3003951, NPL3003952, NPL3003954, NPL3004050, NPL300... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- May 20, 2026
- Recall initiation date
- Apr 8, 2026
- Center classification date
- May 14, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.