3625

• FDA PMA P080025 decided 14 Mar 2011 Active· +3 more in the status table
• FDA GUDID UDI-DI 00613994752178 listed 23 Sep 2014 Listed

• 2 recalls, same reason

  • Ongoing Z-2240-2026 FDA Class II ·initiated 13 May 2026
  • Ongoing Z-2241-2026 FDA Class II ·initiated 13 May 2026

  A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.

• • Ongoing Z-1704-2025 FDA Class II ·initiated 3 Apr 2025

  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.

• • Ongoing Z-0206-2025 FDA Class II ·initiated 24 Sep 2024

  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.

• • Ongoing Z-0372-2025 FDA Class II ·initiated 18 Sep 2024

  The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.

• • Ongoing Z-1691-2024 FDA Class II ·initiated 28 Mar 2024

  inability to reprogram one device

• • Ongoing Z-0780-2024 FDA Class II ·initiated 19 Dec 2023

  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.

• • Ongoing Z-2365-2023 FDA Class II ·initiated 6 Jul 2023

  Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.

• • Ongoing Z-1128-2022 FDA Class II ·initiated 30 Mar 2022

  The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.

• • Ongoing Z-0418-2022 FDA Class II ·initiated 19 Oct 2021

  During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive.

• • Ongoing Z-0201-2022 FDA Class II ·initiated 23 Sep 2021

  A software anomaly may occur with the clinician programmer application.

• • Ongoing Z-2159-2021 FDA Class II ·initiated 9 Jul 2021

  Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing information printed on the shelf box and the sterile pack labeling.

• • Ongoing Z-1368-2021 FDA Class II ·initiated 9 Mar 2021

  There are two issues within this correction action: 1. Cycling Issue: When copying settings from a previously used Activa device to a new Percept PC Implantable Neurostimulator (INS) using the "replacement" function of the A610 clinician programmer application, the cycling feature is not copied properly. 2. Log Fill Issue: When the Percept PC INS System Event log is full, the clinician programmer A610 Software application version 2.0.4584, 2.0.4594, 2.0.4605, or 3.0.1057 crashes when it attempts a reading of the last records in the log.

• • Completed Z-0217-2024 FDA Class II ·initiated 27 May 2022

  There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.

• • Terminated Z-0998-2022 FDA Class II ·initiated 28 Feb 2022

  There is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields not e retained and a " Data Lost" notification being displayed.

• • Terminated Z-3069-2017 FDA Class II ·initiated 17 Mar 2017

  Medtronic received reports that the DBS depth stop did not adequately secure to the lead, which can result in DBS lead placement beyond the intended target.

• • Terminated Z-2645-2016 FDA Class II ·initiated 23 Jun 2016

  Due to the potential for pocket adaptor conductor wire fractures involving DBS Pocket Adaptor Model 64001 and Model 64002, a safety notification was sent to healthcare professionals to reinforce device specific labeling for the handling of pocket adaptors and system integrity checking during implant procedures.

• • Terminated Z-2602-2016 FDA Class II ·initiated 10 Jun 2016

  Medtronic has voluntarily decided to retrieve unused Model 3387S-40 and 3389S-40 DBS leads from three manufacturing lot numbers. During the manufacturing process of a DBS lead component, Medtronic identified the potential for lead insulation damage.

• • Terminated Z-1926-2016 FDA Class II ·initiated 3 May 2016

  Loss of therapy during recharging of device. Reportedly, a charging session was terminated prior to obtaining recharge threshold voltage of 3.615, which triggered rapid battery depletion state. As a result, the device depleted to 1.925 volts in one to two days rather than the typical 30 days. Insufficient coupling between recharger and device during recharge session was found to be key factor.

• • Terminated Z-1617-2015 FDA Class II ·initiated 16 Apr 2015

  Medtronic is providing Important information regarding extension handling during implant procedure after receiving reports of high impedances. This applies to extension Models 37085 and 37086 which can be used with the following implantable Neurostimulators: Activa PC (Model 37601), Activa RC (Model 37612), and the Activa SC (Model 37603).

• • Terminated Z-1147-2015 FDA Class II ·initiated 9 Jan 2015

  Current labeling indicates that cycling improves device longevity in every programming scenario. However, enabling cycling at certain parameter settings may decrease the device battery longevity. With cycling enabled, longevity estimate displayed on the Model 8840Programmer may be inaccurate.

• • Terminated Z-1524-2014 FDA Class II ·initiated 27 Feb 2014

  Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. The use of this feature is determined by the physician and set using the clinician programmer. Current labeling indicates the use of cycling improves device longevity and recharge interval

• 2 recalls, same reason

  • Terminated Z-0278-2014 FDA Class II ·initiated 30 Sep 2013
  • Terminated Z-0279-2014 FDA Class II ·initiated 30 Sep 2013

  Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between groups with Multiple programs or creating program groups. Therapy can be restored with the Physician Recharge mode (RPM) of the Implantable Neurostimulator Recharger (INSR).

• • Terminated Z-1190-2013 FDA Class I ·initiated 8 Feb 2013

  There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits. Medtronic has received reports of DBS leads being damaged at the connector end of the lead when the lead cap is used. The connector end of the lead is the end of the lead connected to the lead extension. Tightening or loosening of the setscrew may twist the setscrew connector block and may damag

• 4 recalls, same reason

  • Terminated Z-0184-2009 FDA Unclassified (pre-2012) ·initiated 14 Jun 2008
  • Terminated Z-0185-2009 FDA Unclassified (pre-2012) ·initiated 14 Jun 2008
  • Terminated Z-0186-2009 FDA Unclassified (pre-2012) ·initiated 14 Jun 2008
  • Terminated Z-0187-2009 FDA Unclassified (pre-2012) ·initiated 14 Jun 2008

  Medtronic has received reports of DBS" leads being damaged at the proximal connector end of the lead when the lead cap is used in the implant procedure. The lead damage is the result of excessive torsion and / or tensile lading of the proximal connector end of the lead. Data also suggest that excessive torque while tightening or loosening the setscrews may twist the setscrew connector block and d

• • Terminated Z-0037-2008 FDA Unclassified (pre-2012) ·initiated 25 Jun 2007

  A software issue may cause a lower than expected battery capacity estimate when evaluating an InterStim II Implantable Neurostimulator (model 3058) with an N'Vision Clinician Programmer(Model 8840) before implant .

• • Terminated Z-0040-2008 FDA Unclassified (pre-2012) ·initiated 25 Jun 2007

  Software issue may cause false low battery alert to be displayed when interrogating an Interstim Implantable Neurostimulator (Model 3023) with an N'Vision Clinician Programmer (Model 8840), or with an Inter Stim iCon Patient Programmer (Model 3037).

• • Terminated Z-1536-06 FDA Unclassified (pre-2012) ·initiated 2 Aug 2006

  Model 3777 Standard Octad Lead (Lot V009545) and Model 3778 Compact Octad Lead (Lot V009546) were mispackaged. The result of this error is that lead kits labeled 3777 lot V009545 may contain a 3778 compact-spaced lead, while those labeled 3778 lot V009546 may contain a 3777 standard-spaced lead. The result of this error is an overall increase or decrease of 14 mm in the electrode coverage.

• • Terminated Z-0370-06 FDA Unclassified (pre-2012) ·initiated 30 Nov 2005

  A safety concern exists regarding the Medtronic Activa Deep Brain Stimulation system instructions for performing MRI (magnetic resonance imaging). Medtronic's instructions have until now recommended a use of a displayed MRI head specific absorption rate (SAR) of not more than 0.4 W/kg. The recommended maximum displayed head SAR is now 0.1 W/kg.

1. 30 Mar 2022 Recall initiated FDA recalls Z-1128-2022
2. 27 May 2022 Recall initiated FDA recalls Z-0217-2024
3. 6 Jul 2023 Recall initiated FDA recalls Z-2365-2023
4. 19 Dec 2023 Recall initiated FDA recalls Z-0780-2024
5. 28 Mar 2024 Recall initiated FDA recalls Z-1691-2024
6. 18 Sep 2024 Recall initiated FDA recalls Z-0372-2025
7. 24 Sep 2024 Recall initiated FDA recalls Z-0206-2025
8. 3 Apr 2025 Recall initiated FDA recalls Z-1704-2025
9. 13 May 2026 Recall initiated FDA recalls Z-2240-2026
10. 13 May 2026 Recall initiated FDA recalls Z-2241-2026

28 earlier events are in the sections above.

Generic name

Sacral plexus percutaneous incontinence-control electrical stimulation system pulse generator

Model / reference

3625

Primary DI / UDI-DI

00613994752178

PMA number

P080025 ↗

P840001 ↗

P960009 ↗

P970004 ↗

FDA product code

MRU, MHY, EZW, GZF, LGW, MFR, NHL, OLM, PJS, QON

GMDN term

Sacral plexus percutaneous incontinence-control electrical stimulation system pulse generator

Device class

Unclassified

Regulation number

876.5270, 882.5870

GUDID distribution status

In Commercial Distribution

Category: Sacral plexus implantable incontinence-control electrical stimulation system

Other devices filed under FDA product code EZW.

• Brio Neurostimulation System Leads, Adaptors, and Extensions by Abbott Medical
• Virtis Sacral Neuromodulation System by Cirtec Medical Corporation
• Axonics Sacral Neuromodulation System by Boston Scientific
• Neuspera Sacral Neuromodulation System by NEUSPERA MEDICAL, INC.
• Interstim Therapy System for Urinary Control by MEDTRONIC NEUROMODULATION

• BB11A61R10

  Class II

  FDA 510(k) K171979 Active Cleared 27 Oct 2017 GUDID on market

• CapSureFix™ Novus

  Class III

  CE/MDR

• Rf Marinr™

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  CE/MDD

• Achieve™

  Class III

  CE/MDD

See all devices from Medtronic, Inc. →