Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
Reported: August 4, 2021 Initiated: July 9, 2021 #Z-2159-2021
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.
Details
- Recalling Firm
- Medtronic Neuromodulation
- Units Affected
- 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
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290. Recalled by Medtronic Neuromodulation. Units affected: 1131 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on August 4, 2021. Severity: Moderate. Recall number: Z-2159-2021.
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