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FDA (Device enforcement)Recalled 2024-06-17class ii

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

Hazard

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

Details from the source

Reason for recall: A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup. Distribution: US Nationwide distribution. Quantity: 211 devices Lot/code info: 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,

UPC codes

0076300092754

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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