Z-2159-2021 Class II Ongoing
FDA device recall Z-2159-2021 was initiated by Medtronic Neuromodulation on Jul 9, 2021 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 1131 units.
Recall details
- Product Type
- Devices
- Report Date
- Aug 4, 2021
- Initiation Date
- Jul 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1131 units
Product description
Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
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.
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
Code information
a) 977A260, PIN 977A20024V, UDI 00763000324353 b) 977A275, PIN 977A20025V, UDI 00763000324360 c) 977A290, PIN 977A20028V, UDI 00763000324377
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2159-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026