Medtronic Inc. Cardiac Rhythm Disease Management: Medical Device Recall in 2015 - (Recall #: Z-0022-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 15, 2015

Date Posted: October 14, 2015

Recall Number: Z-0022-2016

Event ID: 72245

Reason for Recall:

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.

Status: Terminated

Product Quantity: 777 cards

Code Information:

no codes on the cards

Distribution Pattern:

US nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated