Z-0391-2022Class II

Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator

Name: Z-0391-2022 Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
Creator: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Published: 2021-11-08
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-11-08 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) began a recall of Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator on 2021-11-08. FDA classified it as Class II and gives the reason as "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."". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0391-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-08
Posted: 2021-12-16
Terminated: 2026-05-04
Recalling firm: Medtronic, Inc.
Product: Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
Product code: NVZ Pulse Generator, Permanent, Implantable
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."
Root cause tag: labeling and UDI
FDA 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 in commerce: 10 Medical Device Cards
Distribution: US, Canada, Northern Mariana Islands
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0391-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0390-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-22	2021-12-16
Z-0391-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-22	2021-12-16

Product code NVZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)