Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
FDA Recall Z-0390-2022 · Posted None
Recalling FirmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Recall StatusTerminated
Product CodeNVY
Date Initiated2021-11-08
Date Terminated2026-05-04
Product Quantity187 Medical Device Cards
Reason for Recall
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."
Firm Action
On 09-Nov-2021, Medtronic initiated mailing the patient letter, including a corrected Medical Device Identification Card, to impacted patients. In addition, on 08-Nov-2021, physicians following impacted patients were sent a physician letter explaining the correction.
Root Cause
Error in labeling
Distribution Pattern
US, Canada, Northern Mariana Islands
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.