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Recall Observatory FDA recall evidence

Device product

Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.

Z-3073-2024

June 17, 2024

Class II

Product summary

Firm
Medtronic Neuromodulation
Event
Event 95131
Status
Ongoing
Classification
Class II
Quantity
211 devices
Official record key
device-enforcement:Z-3073-2024

Official wording

Reason: A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup.

Code information: GTIN 0076300092754, serial numbers: NPV0082351, NPV0085575, NPV0082308, NPV0082309, NPV0082314, NPV0082328, NPV0082329, NPV0082349, NPV0082412, NPV0082483, NPV0082494, NPV0082608, NPV0082631, NPV0082646, NPV0082684, NPV0082689, NPV0082690, NPV0082691, NPV0082756, NPV0082866, NPV0082869, NPV0082899, NPV0082921, NPV0083001, NPV0083071, NPV0083084, NPV0083116, NPV0083125, NPV0083171, NPV0083507, NPV0083577, NPV0083629, NPV0083632, NPV0083853, NPV0083883, NPV0083917, NPV0083944, NPV0083948, NPV0083954, NPV0083972, NPV0084077, NPV0084084, NPV0084104, NPV0084113, NPV0084119, NPV0084125, NPV0084177, NPV0084211, NPV0084253, NPV0084283, NPV0084293, NPV0084295, NPV0084304, NPV0084305, NPV0084311, NPV0084312, NPV0084313, NPV0084317, NPV0084330, NPV0084340, NPV0084353, NPV0084355, NPV0084428, NPV0084473, NPV0084523, NPV0084610, NPV0084634, NPV0084679, NPV0084681, NPV0084695, NPV0084697, NPV0084751, NPV0084753, NPV0084754, NPV0084767, NPV0085004, NPV0085034, NPV0085036, NPV0085057, NPV0085059, NPV0085077, NPV0085081, NPV0085473, NPV0085510, NPV0085529, NPV0085580, NPV0085601, NPV0085616, NPV0085626, NPV0085631, NPV0085647, NPV0085653, NPV0082276, NPV0082278, NPV0082281, NPV0082304, NPV0082313, NPV0082316, NPV0082320, NPV0082340, NPV0082352, NPV0082358, NPV0082376, NPV0082377, NPV0082418, NPV0082421, NPV0082431, NPV0082450, NPV0082451, NPV0082476, NPV0082480, NPV0082508, NPV0082513, NPV0082514, NPV0082520, NPV0082524, NPV0082537, NPV0082539, NPV0082543, NPV0082559, NPV0082562, NPV0082569, NPV0082571, NPV0082572, NPV0082591, NPV0082635, NPV0082666, NPV0082674, NPV0082695, NPV0082701, NPV0082722, NPV0082723, NPV0082740, NPV0082769, NPV0082779, NPV0082782, NPV0082789, NPV0082806, NPV0082859, NPV0082871, NPV0082879, NPV0082882, NPV0082897, NPV0082913, NPV0082915, NPV0082916, NPV0082923, NPV0082928, NPV0082931, NPV0082944, NPV0082945, NPV0082949, NPV0082952, NPV0082960, NPV0082963, NPV0083005, NPV0083027, NPV0083036, NPV0083047, NPV0083052, NPV0083053, NPV0083104, NPV0083129, NPV0083134, NPV0083175, NPV0083178, NPV0083189, NPV0083192, NPV0083200, NPV0083225, NPV0083228, NPV0083229, NPV0083230, NPV0083237, NPV0083277, NPV0083289, NPV0083302, NPV0083312, NPV0083329, NPV0083332, NPV0083344, NPV0083345, NPV0083349, NPV0083371, NPV0083396, NPV0083484, NPV0083506, NPV0083522, NPV0083526, NPV0083555, NPV0083575, NPV0083596, NPV0083604, NPV0083613, NPV0083618, NPV0083646, NPV0083649, NPV0083688, NPV0083708, NPV0083712, NPV0083716, NPV0083729, NPV0083738, NPV0083827, NPV0083842, NPV0083845, NPV0083846, NPV0083847, NPV0083859, NPV0083937, NPV0084126.

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup.