Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
Check against the official notice below — it lists the full affected range.
Medtronic Inc. is recalling Medical Device Identification Cards provided to patients with Astra XT DR implantable pulse generators. The back of some cards contained an incorrect statement claiming "This patient has a complete MR conditional system implanted," when this was not accurate for the devices in question. The recall affects 10 cards distributed in the US, Canada, and Northern Mariana Islands.
The erroneous statement on the identification cards could mislead patients or healthcare providers about the MR (magnetic resonance) compatibility of the implanted device, potentially creating safety concerns during medical procedures. The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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."
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 Quantity: 10 Medical Device Cards Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.