FDA-Device2021-12-22Class II
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."
Sold states
US, Canada, Northern Mariana Islands
Affected count
187 Medical Device Cards
Manufactured in
8200 Coral Sea St Ne, Mounds View, MN, United States
Products
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0390-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief