Medtronic Inc. Cardiac Rhythm Disease Management recalls Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the imp…

Recall date

September 15, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0022-2016

FDA classification

Class II

Brand / firm

Medtronic Inc. Cardiac Rhythm Disease Management

Sold / distributed

US nationwide distribution.

Why it was recalled

Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance (MR) Conditional system, when in fact, not all of their implanted leads have been FDA approved as MR Conditional.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the implanted pacing system components currently registered to the patient. The back of the card lists patient's following physician as well as specific messaging regarding the MR conditional status of the device components, where applicable. This card is provided to the patient by Medtronic after device registration.