Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 30, 2017
DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to multiple accessories used in DBS lead implant procedures. Among these accessories is the DBS lead holder, also referred to as the lead depth stop. The lead holder affixes to the DBS lead during the lead implant procedure, marking the distance to the lead tip and providing control of DBS lead depth during implant b
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Neuromodulation recalled DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models… - a moderate-severity action.
DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models… was recalled by Medtronic Neuromodulation in August 30, 2017. Reason: Medtronic received reports that the DBS depth stop did not adequately secure to the lead, which can result in…. Check the official notice for the remedy. Verify recall #Z-3069-2017 with the FDA Devices before acting.
The recall
Medtronic Neuromodulation issued this moderate-severity FDA Devices recall-Medtronic received reports that the DBS depth stop did not adequately secure to the lead, which can result in….
- Moderate
- severity level
- 86K units
- affected scope
- Class II
- classification
- August 30, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3069-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-3069-2017) was formally reported on August 30, 2017, with the manufacturer initiating the action on March 17, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Neuromodulation is listed as the recalling firm, operating out of Minneapolis, MN. Federal records list the affected scope as 86,024.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide Distribution - US including AL, AR, AZ, CA,CO, CT, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,M MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA,…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
86,024
Related Recalls
6
3 from same agency
Product description
DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to multiple accessories used in DBS lead implant procedures. Among these accessories is the DBS lead holder, also referred to as the lead depth stop. The lead holder affixes to the DBS lead during the lead implant procedure, marking the distance to the lead tip and providing control of DBS lead depth during implant by interfacing with the stereotactic system
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-3069-2017 |
| Date reported | August 30, 2017 |
| Date initiated | March 17, 2017 |
| Recalling firm | Medtronic Neuromodulation |
| Firm location | Minneapolis, MN |
| Affected scope | 86,024 |
| Distribution | Worldwide Distribution - US including AL, AR, AZ, CA,CO, CT, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,M MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. Fore… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-3069-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to multiple accessories used in DBS lead implant procedures. Among these accessories is the DBS lead holder, also referred to as the lead depth stop. The lead holder affixes to the DBS lead during the lead implant procedure, marking the distance to the lead tip and providing control of DBS lead depth during implant by interfacing with the stereotactic system. Recalled by Medtronic Neuromodulation. Units affected: 86,024.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 30, 2017. Severity: Moderate. Recall number: Z-3069-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US including AL, AR, AZ, CA,CO, CT, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,M MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. Foreign Distribution: India, ANZ, Taiwan, Hong Kong, Canada, China, Japan, Korea, Malaysia, Philippines, Singapore, Thailand, Indonesia, Vietnam, Albania, Algeria, Austria, Belarus, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, India, Iran, Iraq, Israel, Italy, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malta, Morocco, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, United Kingdom, Argentina, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Mexico, Panama, Peru, Puerto Rico, Uruguay, and Venezuela..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3069-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 30, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.