FDA recall Z-0391-2022

Product

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

US, Canada, Northern Mariana Islands

Key facts

Status

Terminated

Initiation date

2021-11-08

Report date

2021-12-22

Termination date

2026-05-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mounds View, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0391-2022