Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
FDA Device Recall #Z-0391-2022 — Class II — November 8, 2021
Recall Summary
| Recall Number | Z-0391-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 8, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Location | Mounds View, MN |
| Product Type | Devices |
| Quantity | 10 Medical Device Cards |
Product Description
Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
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."
Distribution Pattern
US, Canada, Northern Mariana Islands
Lot / Code Information
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
Other Recalls from Medtronic Inc., Cardiac Rhythm and He...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1707-2023 | Class I | ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Num... | May 10, 2023 |
| Z-1737-2023 | Class I | CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Numbe... | May 10, 2023 |
| Z-1722-2023 | Class I | ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model N... | May 10, 2023 |
| Z-1746-2023 | Class I | CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number... | May 10, 2023 |
| Z-1739-2023 | Class I | CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model ... | May 10, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.