—#209554

Product

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

FDA product code: EZW — Stimulator, Electrical, Implantable, For Incontinence
Device class: Class 3
Medical specialty: Gastroenterology, Urology
PMA numbers: P970004S340, P080025S235
Affected 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, 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.

Why it was recalled

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

Root cause (FDA determination)

Software change control

Action the firm took

The recalling firm issued letters dated June 2024 beginning 6/17/2024 to the Medtronic Field Service Representatives to notify consignees and retrieve a subset of the InterStim Smart Programmer and Communicator Kits (TH90Q01). The notification informed the Field Service Representatives of the Field Corrective Action and provided instruction on notifying the consignees and retrieving the device(s). Beginning on June 17, 2024, US initiated communications and notifications dated June 2024 were physically hand-delivered to each consignee with the impacted device(s). The letter described the issue and provided Required Customer Actions, which included completing and signing the Customer Confirmation form acknowledging receipt of the notification and sharing the notice with all that needed to be aware. An appendix was enclosed which listed the serial numbers of the affected products.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2024-06-17
Posted by FDA: 2024-09-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209554. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.