Class 2 Device Recall Medtronic InterStim

• Date Initiated by Firm: June 17, 2024
• Date Posted: September 06, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3073-2024
• Recall Event ID: 95131
• PMA Number: P970004S340 P080025S235
• Product Classification: Stimulator, electrical, implantable, for incontinence - Product Code EZW
• Product: Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.
• 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.
• Recalling Firm/ Manufacturer: Medtronic Neuromodulation; 7000 Central Ave Ne; Minneapolis MN 55432-3568
• Manufacturer 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.
• FDA Determined Cause: Software change control
• Action: 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.
• Quantity in Commerce: 211 devices
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = EZW