Z-2159-2021Class II

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

Name: Z-2159-2021 Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
Creator: Medtronic Neuromodulation
Published: 2021-07-09
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2021-07-09 / Open, Classified / root cause: labeling and UDI

FDA source

Medtronic Neuromodulation began a recall of Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290 on 2021-07-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2159-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-07-09
Posted: 2021-07-28
Recalling firm: Medtronic Neuromodulation
Product: Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm initiated the recall on 07/07/2021 by regionally approve method (e.g. courier, registered mail, hand delivery). The firm is requesting the return of the devices.
Quantity in commerce: 1131 units
Distribution: Austria, Belgium, Brazil, Canary Islands, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, United Kingdom
Product codes and lots: a) 977A260, PIN 977A20024V, UDI 00763000324353 b) 977A275, PIN 977A20025V, UDI 00763000324360 c) 977A290, PIN 977A20028V, UDI 00763000324377

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2159-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2159-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-04	2021-07-28

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)