Medtronic Neuromodulation: Medical Device Recall in 2021 - (Recall #: Z-2159-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 9, 2021

Date Posted: August 4, 2021

Recall Number: Z-2159-2021

Event ID: 88272

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.

Status: Ongoing

Product Quantity: 1131 units

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

Voluntary or Mandated:

Voluntary: Firm initiated