- Recalling firm
- Medtronic Neuromodulation
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- 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, N
- Units affected
- 10165 units
- Distribution pattern
- Worldwide distribution.
- Firm location
- Minneapolis, MN, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2201-2026
- Recall initiated
- April 8, 2026
- FDA classification date
- May 14, 2026
- FDA report date
- May 20, 2026
- FDA event ID
- 98750
- Last updated on HTM Vibe
- July 24, 2026