Medtronic Vectris SureScan MRI recall: Labeling Error
Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
Why was Medtronic Vectris SureScan MRI 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) 977A260, PIN 977A20024V, UDI 00763000324353 b) 977A275, PIN 977A20025V, UDI 00763000324360 c) 977A290, PIN 977A20028V, UDI 00763000324377
- Product
- Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 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
- Recall date
- August 4, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)