Recall Z-0391-2022 ยท NVZ Pulse Generator, Permanent, Implantable
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
| Date | Nov 8, 2021 |
| Status | Terminated |
| 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." |
| Root cause | Error in labeling |
| 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. |
| Quantity | 10 Medical Device Cards |
| Distribution | US, Canada, Northern Mariana Islands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.