Recall Z-2159-2021— Medtronic Neuromodulation

Name: FDA recall Z-2159-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-09

Class II · Ongoing

Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2021-07-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290. Reason: 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..

Recalling firm: Medtronic Neuromodulation
Classification: Class II
Status: Ongoing
Initiated: 2021-07-09
Firm location: Minneapolis, MN, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.