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Terminated

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

FDA Recall Z-0391-2022 · Posted None

Recalling FirmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Recall StatusTerminated
Product CodeNVZ
Date Initiated2021-11-08
Date Terminated2026-05-04
Product Quantity10 Medical Device Cards

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."

Firm 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.

Root Cause

Error in labeling

Distribution Pattern

US, Canada, Northern Mariana Islands

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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