Medtronic Vectris SureScan MRI Recall: Incorrect Lead Electrode Spacing
Medtronic recalls Vectris SureScan MRI devices with specific catalog numbers due to incorrect lead electrode spacing information on packaging. This could lead to improper use during MRI procedures.
Lower-risk recall
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.
Contact the company
What happened, in plain English
Medtronic is recalling specific models of Vectris SureScan MRI devices because the lead kits have incorrect electrode spacing details on their packaging. This could cause improper use during MRI procedures if the wrong spacing is followed. Read more at govinfonow.com/recall/62221-medtronic-vectris-surescan-mri-recall-incorrect-lead-electrode-spacing.
Source Summary by GovInfoNow · govinfonow.com/recall/62221-medtronic-vectris-surescan-mri-recall-incorrect-lead-electrode-spacing · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2159-2021
Cite this page
“Medtronic Vectris SureScan MRI Recall: Incorrect Lead Electrode Spacing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62221-medtronic-vectris-surescan-mri-recall-incorrect-lead-electrode-spacing. Based on FDA recall #Z-2159-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2159-2021%22&limit=1).
Why it’s dangerous
The lead kits contain incorrect electrode spacing information printed on the shelf box and sterile pack labels. This could lead to improper use during MRI procedures if the wrong spacing is followed, potentially causing ineffective treatment or safety issues.
Who’s affected
Patients and medical professionals using the recalled Vectris SureScan MRI devices with catalog numbers 977A260, 977A275, or 977A290 are affected. Those who have the specific PINs and UDI numbers listed are most at risk.
How to tell if you have this one
Check your Vectris SureScan MRI device for catalog numbers 977A260, 977A275, or 977A290. Look for the specific PINs and UDI numbers listed in the recall notice.
- Brand
Medtronic- Category
Medical device
What to do — step by step
Check Device Details
Verify your device's catalog number and PIN/UDI against the listed numbers to confirm if it is recalled.
How this recall unfolded
Recall timeline
FDA published this recall 26 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2159-2021 (July 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2159-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.