Class 2 Device Recall InterStim

• Date Initiated by Firm: April 03, 2025
• Date Posted: April 30, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1704-2025
• Recall Event ID: 96688
• PMA Number: P080025
• Product Classification: Stimulator, electrical, implantable, for incontinence - Product Code EZW
• Product: Enhanced Verify Evaluation Handset (CFN HH90130FA)
• Code Information: UDI-DI 00763000930042 Serial Nos/Lots: NPN0076461 NPN0076462 NPN0076465 NPN0076466 NPN0076467 NPN0076468 NPN0076469 NPN0076470 NPN0076471 NPN0076472 NPN0076473 NPN0076474 NPN0076475 NPN0076476 NPN0076477 NPN0076479 NPN0076480 NPN0076482 NPN0076483 NPN0076485 NPN0076486 NPN0076487 NPN0076488 NPN0076489 NPN0076490 NPN0076491 NPN0076492 NPN0076493 NPN0076494 NPN0076495 NPN0076496 NPN0076497 NPN0076498 NPN0076499 NPN0076500 NPN0076501 NPN0076502 NPN0076504 NPN0076505 NPN0076506 NPN0076507 NPN0076508 NPN0076509 NPN0076510 NPN0076511 NPN0076512 NPN0076513 NPN0076514 NPN0076515 NPN0076516 NPN0076517 NPN0076518 NPN0076520 NPN0076522 NPN0076523 NPN0076524 NPN0076525 NPN0076526 NPN0076527 NPN0076528 NPN0076529 NPN0076530 NPN0076531 NPN0076532 NPN0076533 NPN0076534 NPN0076535 NPN0076536 NPN0076537 NPN0076538 NPN0076539 NPN0076540 NPN0076541 NPN0076542 NPN0076543 NPN0076545 NPN0076546 NPN0076548 NPN0076550 NPN0076551 NPN0076552 NPN0076553 NPN0076554 NPN0076555 NPN0076556 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• Recalling Firm/ Manufacturer: Medtronic Neuromodulation; 7000 Central Ave Ne; Minneapolis MN 55432-3568
• For Additional Information Contact: Laurel Hood; 763-514-2000
• Manufacturer Reason for Recall: Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.
• FDA Determined Cause: Device Design
• Action: Firm began notifying Medtronic representatives on April 3, 2025. If impacted devices were found to be with a consignee, the representative will connect with the consignee to provide a copy of the Customer Letter, obtain a signed copy of the Customer Confirmation Form, and retrieve the impacted device. Customers were informed that their Medtronic representative will collect the affected devices and arrange for replacement devices.
• Quantity in Commerce: 534
• Distribution: US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MD, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, TX, WA, WI.
• 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.