Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88272

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 09, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medtronic Neuromodulation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2159-2021
Recall number
Z-2159-2021
Initiated
July 09, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Neuromodulation
Quantity
1131 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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