Recall archive / FDA device enforcement
Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator — FDA record Z-0391-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 8, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
- 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."
- Classification
- Class II
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Quantity
- 10 Medical Device Cards
- Agency-reported status
- Terminated
- Source record identifier
- Z-0391-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Astra XT DR implantable pulse generator, Product Number/CFN X2DR01, UDI 00763000108953, Serial Numbers: RNH655287S, RNH648107S, RNH645452S, RNH634608S, RNH642593S, RNH638740S, RNH635040S, RNH636809S, RNH633755S UDI 00643169634671, Serial Numbers: RNH612514S |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US, Canada, Northern Mariana Islands
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Dec 22, 2021
- Recall initiation date
- Nov 8, 2021
- Center classification date
- Dec 16, 2021
- Termination date
- May 4, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.