PMA · Approved
Recalled · Class I · 2026Medtronic Activa Tremor Control System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Approved on Jul 31, 1997 through premarket approval, which rests on the device’s own clinical evidence after a 456-day review. It has a Class I recall. It has been recalled 20 times, including a Class I recall.
- Decided
- Jul 31, 1997
- Review
- 456 days
- Class
- Class III
- Product code
- MHY
- Recalls
- 20 (1 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P960009 has 528 supplements since 1998: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1998 | 2 |
| 1999 | 5 |
| 2000 | 5 |
| 2001 | 7 |
| 2002 | 5 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 4 |
| 2006 | 5 |
| 2007 | 3 |
| 2008 | 7 |
| 2009 | 18 |
| 2010 | 28 |
| 2011 | 31 |
| 2012 | 25 |
| 2013 | 23 |
| 2014 | 25 |
| 2015 | 31 |
| 2016 | 27 |
| 2017 | 35 |
| 2018 | 27 |
| 2019 | 33 |
| 2020 | 26 |
| 2021 | 23 |
| 2022 | 30 |
| 2023 | 24 |
| 2024 | 25 |
| 2025 | 33 |
| 2026 | 18 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 13, 2026 | Class II | Z-2240-2026 | Under Investigation by firm | A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. |
| May 13, 2026 | Class II | Z-2241-2026 | Under Investigation by firm | A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. |
| Sep 24, 2024 | Class II | Z-0206-2025 | Under Investigation by firm | 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. |
| Sep 18, 2024 | Class II | Z-0372-2025 | Under Investigation by firm | The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use. |
| May 27, 2022 | Class II | Z-0217-2024 | Labeling Change Control | 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. |
| Mar 30, 2022 | Class II | Z-1128-2022 | Under Investigation by firm | The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system. |
| Oct 19, 2021 | Class II | Z-0418-2022 | Under Investigation by firm | 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… |
| Sep 23, 2021 | Class II | Z-0201-2022 | Software design | A software anomaly may occur with the clinician programmer application. |
| Mar 9, 2021 | Class II | Z-1368-2021 | Under Investigation by firm | 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… |
| Mar 17, 2017 | Class II | Z-3069-2017 | Process control | 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. |
| Jun 23, 2016 | Class II | Z-2645-2016 | Nonconforming Material/Component | 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… |
| Jun 10, 2016 | Class II | Z-2602-2016 | Process design | 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… |
| Apr 16, 2015 | Class II | Z-1617-2015 | Under Investigation by firm | 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… |
| Sep 30, 2013 | Class II | Z-0279-2014 | Software design | 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… |
| Feb 8, 2013 | Class I | Z-1190-2013 | Process control | 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… |
| Jun 14, 2008 | Not classified | Z-0187-2009 | Process design | 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… |
| Jun 14, 2008 | Not classified | Z-0184-2009 | Process design | 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… |
| Jun 14, 2008 | Not classified | Z-0186-2009 | Process design | 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… |
| Jun 14, 2008 | Not classified | Z-0185-2009 | Process design | 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… |
| Nov 30, 2005 | Not classified | Z-0370-06 | Other | 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… |
The 5 latest of 20 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MHY devicesMHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MHY
44in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHY
Too few MHY 510(k)s in any year since 2007 to give a median.
Recalls per year · MHY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHY
3,373in 2025
MAUDE reports naming product code MHY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | — | 3 | 710 |
| 2008 | 7 | — | 4 | 1,450 |
| 2009 | 18 | — | 0 | 1,314 |
| 2010 | 28 | — | 0 | 1,532 |
| 2011 | 31 | — | 0 | 1,597 |
| 2012 | 25 | — | 2 | 2,382 |
| 2013 | 23 | — | 1 | 2,845 |
| 2014 | 25 | — | 0 | 2,621 |
| 2015 | 18 | — | 0 | 3,088 |
| 2016 | 37 | — | 1 | 3,559 |
| 2017 | 45 | — | 1 | 3,561 |
| 2018 | 36 | — | 1 | 4,494 |
| 2019 | 42 | — | 0 | 2,817 |
| 2020 | 37 | — | 1 | 2,673 |
| 2021 | 36 | — | 3 | 2,427 |
| 2022 | 34 | — | 1 | 2,257 |
| 2023 | 31 | — | 1 | 3,489 |
| 2024 | 47 | — | 1 | 4,386 |
| 2025 | 44 | — | 1 | 3,373 |
| 2026 | 29 | — | 2 | — |
https://510kreport.com/device/P960009 · printed Nov 6, 2026
Cite this page
510(k) Report. “P960009: Medtronic Activa Tremor Control System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P960009
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026