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Medtronic Neuromodulation

United Statesfrom the FDA registration address FDA establishment FEI 2182207

Devices
5
Registrations
FDA
FDA recalls
18248 ongoing since 2021 (51 open in total)
3 open since before 2021

What Medtronic Neuromodulation makes

Medtronic Neuromodulation makes a range of medical devices, including software such as SureTune4, and systems like the InterStim Therapy System for urinary control and spinal cord stimulation systems including Itrel, Synergy and Intellis. The company's portfolio also includes associated leads like Pisces, Specify, and Vectris.

The company's devices are classified as Class II and Class III, and are listed in the FDA's 510k and PMA registries. Medtronic Neuromodulation is based in the US.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue5

Newest first, rows 1-5 of 5

Company details

FDA FEI number
2182207
Address
7000 Central Ave., N.E., Minneapolis, MN, 55432

FDA recalls182

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 182 recalls initiated by MEDTRONIC NEUROMODULATION, the earliest on 2006-06-06 and the most recent on 2026-05-13. By recorded status: 51 ongoing, 130 terminated and 1 with another status. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, sterility or contamination, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 4
  • 2018 2
  • 2019 2
  • 2020 3
  • 2021 9
  • 2022 12
  • 2023 9
  • 2024 12
  • 2025 5
  • 2026 3

121 initiated before 2017

Showing the 10 most recent of 182 recalls.

  • 2026

    • 13 May 2026 Z-2240-2026 Class II Ongoing A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. Distribution: Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands,…
      Full distribution text Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom.
      Submission number: P960009
    • 13 May 2026 Z-2241-2026 Class II Ongoing A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. Distribution: Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands,…
      Full distribution text Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom.
      Submission number: P960009
    • 8 Apr 2026 Z-2201-2026 Class II Ongoing Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all. Distribution: Worldwide distribution. Submission number: P860004

  • 2025

    • 3 Dec 2025 Z-1043-2026 Class II Ongoing Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure. Distribution: Worldwide - US Nationwide distribution. Submission number: P840001S594
    • 20 Nov 2025 Z-0996-2026 Class II Ongoing Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS. Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Aruba, Australia, Austria, Belgium, Bosnia And…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Argentina, Aruba, Australia, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Malta, Mauritius, Mexico, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Poland, Portugal, Qatar, Reunion, Russia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay.
      Submission number: P840001S594
    • 3 Apr 2025 Z-1704-2025 Class II Ongoing 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. 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,…
      Full distribution text 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.
      Submission number: P080025
    • 4 Mar 2025 Z-1543-2025 Class II Ongoing There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used. Distribution: Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Austria, Belgium, Bulgaria, Canary Islands,…
      Full distribution text Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Austria, Belgium, Bulgaria, Canary Islands, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Luxembourg, Malta, Netherlands, Northern Ireland, Norway, Poland, Portugal, Puerto Rico, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
      Submission number: P840001S512
    • 9 Jan 2025 Z-1506-2025 Class II Ongoing Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump. Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Czech Republic, France,…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Puerto Rico, Spain, Sweden, Switzerland, United Kingdom.
      Submission number: P860004

  • 2024

    • 21 Nov 2024 Z-0771-2025 Class II Ongoing Software issues were identified in application version 2.x. Distribution: Worldwide - US Nationwide distribution. Submission number: P860004S404
    • 21 Nov 2024 Z-0772-2025 Class II Ongoing Software issues were identified in application version 2.x. Distribution: Worldwide - US Nationwide distribution. Submission number: P860004S404
Show the 25 most recent of 182 recalls

  • 2024

    • 21 Nov 2024 Z-0773-2025 Class II Ongoing Software issues were identified in application version 2.x. Distribution: Worldwide - US Nationwide distribution. Submission number: P860004S404
    • 21 Nov 2024 Z-0774-2025 Class II Ongoing Software issues were identified in application version 2.x. Distribution: Worldwide - US Nationwide distribution.
    • 24 Sep 2024 Z-0206-2025 Class II Ongoing A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear. Distribution: International distribution to the countries of Germany, UK, and Israel. Submission number: P960009
    • 18 Sep 2024 Z-0372-2025 Class II Ongoing The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use. Distribution: Worldwide - US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, MD, MI, MN, MO, NC, NJ, OH, PA, SC, TX,…
      Full distribution text Worldwide - US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, MD, MI, MN, MO, NC, NJ, OH, PA, SC, TX, VA, and WA. The countries of Austria, Belgium, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and United Kingdom.
      Submission numbers: P840001, P960009, P970004, P080025
    • 11 Sep 2024 Z-0137-2025 Class II Ongoing Potential for error and inability to interrogate pump due to data corruption in the pump memory. Distribution: US Nationwide distribution in the state of Mississippi.
    • 21 Aug 2024 Z-0132-2025 Class II Ongoing Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements. Distribution: Worldwide distribution.
    • 17 Jun 2024 Z-3073-2024 Class II Ongoing 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. Submission numbers: P970004S340, P080025S235
    • 15 May 2024 Z-2427-2024 Class II Ongoing Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility. Distribution: Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Belgium, Bolivia,…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Canary Islands, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Islamic Republic Of, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic Of, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, Uruguay, Viet Nam.
    • 10 May 2024 Z-2352-2024 Class II Ongoing Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion. Distribution: Worldwide Distribution: US (nationwide) and OUS (foreign) countries of: Argentina, Aruba, Australia, Austria, Belgium,…
      Full distribution text Worldwide Distribution: US (nationwide) and OUS (foreign) countries of: Argentina, Aruba, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, Colombia, Cyprus, Czech Rep, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Guadeloupe, Germany, Greece, Hong Kong, Hungary, Indonesia, Italy, Iran, Islamic Republic, Iraq, Ireland, Jordan, Kazakhstan, Korean Republic of, Kuwait, Latvia, Lebanon, Lithuania, Libya, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherland, New Zealand, Norway, Oman, Panama, Pakistan, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirate, and United Kingdom.
      Submission number: P860004
    • 28 Mar 2024 Z-1691-2024 Class II Ongoing inability to reprogram one device Distribution: International distribution in the country of UK. Submission number: P840001

  • 2023

    • 19 Dec 2023 Z-0780-2024 Class II Ongoing Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief. Distribution: Germany Submission number: P840001
    • 13 Nov 2023 Z-0614-2024 Class II Ongoing Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling. Distribution: Worldwide Submission number: P860004
    • 13 Nov 2023 Z-0615-2024 Class II Ongoing Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling. Distribution: Worldwide Submission number: P860004
    • 19 Oct 2023 Z-0354-2024 Class II Ongoing Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language. Distribution: International distribution to the countries of S. Korea and Turkey.
    • 6 Jul 2023 Z-2365-2023 Class II Ongoing Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date. Distribution: International distribution to the country of Iran. Submission numbers: P070004S001, P080025

Frequently asked questions

How many devices does MEDTRONIC NEUROMODULATION have in the registry?

The registry currently lists 5 devices for MEDTRONIC NEUROMODULATION. Devices recorded under merged duplicate company entries are counted once.

Which registries list MEDTRONIC NEUROMODULATION's devices?

Among its 5 most recently registered devices, MEDTRONIC NEUROMODULATION has devices listed in FDA 510(k) (1 device) and FDA PMA (4 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do MEDTRONIC NEUROMODULATION's devices fall under?

Among its 5 most recently registered devices, the classes recorded for MEDTRONIC NEUROMODULATION's devices are Class II and Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for MEDTRONIC NEUROMODULATION?

FDA recall records list 182 recalls initiated by MEDTRONIC NEUROMODULATION, the most recent initiated on 13 May 2026. 51 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from MEDTRONIC NEUROMODULATION in the registry?

The most recently registered devices listed for MEDTRONIC NEUROMODULATION include SureTune4 Software, Altaviva, InterStim® Therapy System, Verify® Evaluation System and INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company.