Recall Z-0390-2022— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II · Completed
Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2021-11-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72. Reason: 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.".
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Classification
- Class II
- Status
- Completed
- Initiated
- 2021-11-08
- Firm location
- Mounds View, MN, United States
Product description
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
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."
Data sourced from openFDA. This site is unofficial and independent of the FDA.