FDA Device recall Z-0391-2022
Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
- FDA Device
- Class II
- terminated
- Published 2021-12-22
On 2021-12-22 the FDA classified a Class II recall of Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing 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 condition….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0391-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-08 |
| Published | 2021-12-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | n/a |
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."
Identifiers
| code_info | Astra XT DR implantable pulse generator, Product Number/CFN X2DR01, UDI 00763000108953, Serial Numbers: RNH655287S,…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Medtronic Cardiac Rhythm And Heart Failure Crhf
- ICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1
FDA Device · Class I · 2023-06-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf
All Medtronic Cardiac Rhythm And Heart Failure Crhf recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0391-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.