FDA-Device2021-12-22Class II
Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
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
10 Medical Device Cards
Manufactured in
8200 Coral Sea St Ne, Mounds View, MN, United States
Products
Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0391-2022Don't want to check this manually?
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