CLASS II ONGOING Device recall · Reported 4 Aug 2021 · FDA Enforcement Report

Medtronic Vectris SureScan MRI recalled by Medtronic Neuromodulation

Medtronic Neuromodulation is recalling Medtronic Vectris SureScan MRI. The recall was initiated on 9 Jul 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) 977A260, PIN 977A20024V, UDI 00763000324353 b) 977A275, PIN 977A20025V, UDI 00763000324360 c) 977A290, PIN 977A20028V, UDI 00763000324377

Quantity recalled1131 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2159-2021
FDA event ID: 88272
Recalling firm: Medtronic Neuromodulation, Minneapolis, MN
Classification: Class II
Status: Ongoing
Recall initiated: 9 Jul 2021
FDA classified: 28 Jul 2021
Reported: 4 Aug 2021
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Lead & Heavy Metals
Device type: Imaging Equipment

Timeline

9 Jul 2021	Recall initiated by company
28 Jul 2021	Classified by FDA	+19 days
4 Aug 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for 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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290

Where it was distributed

Austria, Belgium, Brazil, Canary Islands, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, United Kingdom

Questions about this recall

Is Medtronic Vectris SureScan MRI recalled?

Yes. Medtronic Neuromodulation recalled Medtronic Vectris SureScan MRI on 9 Jul 2021. The recall is Class II and its status is Ongoing. Recall number Z-2159-2021.

Why was it recalled?

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.

Which lots are affected?

a) 977A260, PIN 977A20024V, UDI 00763000324353 b) 977A275, PIN 977A20025V, UDI 00763000324360 c) 977A290, PIN 977A20028V, UDI 00763000324377

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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