Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
Check against the official notice below — it lists the full affected range.
Medtronic is recalling specific Vectris SureScan MRI lead kits (catalog numbers 977A260, 977A275, and 977A290) distributed across Europe and Brazil. A total of 1,131 units are affected. The recalled products have incorrect lead electrode spacing information printed on the shelf box and sterile pack labeling, which could affect the accuracy of the product information available to healthcare providers during implantation procedures.
The affected devices include specific product identification numbers (PINs 977A20024V, 977A20025V, and 977A20028V) with corresponding unique device identifiers. The recall notice does not specify a remedy or instructions for consumers regarding what steps they should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: Austria, Belgium, Brazil, Canary Islands, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, United Kingdom Quantity: 1131 units Lot/code info: a) 977A260, PIN 977A20024V, UDI 00763000324353 b) 977A275, PIN 977A20025V, UDI 00763000324360 c) 977A290, PIN 977A20028V, UDI 00763000324377
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.