Medtronic Vectris SureScan MRI lead kits recalled for incorrect labeling
Medtronic Neuromodulation is recalling 1131 units of Vectris SureScan MRI lead kits with incorrect electrode spacing information on packaging labels. This could affect proper device installation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device recall involving labeling errors with no reported adverse events. The incorrect electrode spacing information could affect proper device installation, qualifying it as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medtronic Neuromodulation has issued a Class II recall of 1131 units of Vectris SureScan MRI lead kits (Catalog Numbers 977A260, 977A275, and 977A290). The recall is due to incorrect lead electrode spacing information printed on the shelf box and sterile pack labeling.
The Vectris SureScan MRI is an implantable neuromodulation device. The lead electrode spacing is a critical specification that determines proper positioning and function of the device during implantation.
Specific catalog numbers affected contain the wrong electrode spacing information on their packaging labels, which could result in improper installation of the device.
The affected devices were distributed internationally to Austria, Belgium, Brazil, Canary Islands, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, and the United Kingdom.
The recalled product
- Product
- Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 1,131
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- a) 977A260
- PIN 977A20024V
- UDI 00763000324353 b) 977A275
- PIN 977A20025V
- UDI 00763000324360 c) 977A290
- PIN 977A20028V
- UDI 00763000324377
Distribution
Distribution scope not specified by the agency.
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