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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
Recalled December 22, 2021 · FDA recall Z-0390-2022 · 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." · FDA Class II
Units
187 Medical Device Cards
Sold at
US, Canada, Northern Mariana Islands
Description
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."
Product
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
Manufacturer(s)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →