FDA Recall
Completed
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
Recall: Z-0390-2022
·
Initiated November 8, 2021
Recall
- Recall Number
- Z-0390-2022
- Event Number
- 89054
- Firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- FEI Number
- 2182208
- Product Code
- NVY
- Status
- Completed
- Root Cause
- Error in labeling
- Initiated
- November 8, 2021
- Address
- 8200 Coral Sea St Ne, Mounds View, MN, 55112-4391
Description
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."
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.
Distribution
US, Canada, Northern Mariana Islands
Quantity
187 Medical Device Cards